A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting

Atopic Dermatitis Clinical Trial

— UP-TAINED  

Official title:

Non-Interventional, Prospective Observational Cohort Study to Investigate the Effectiveness and Sustained Disease Control of an Upadacitinib Therapy in Moderate to Severe Atopic Dermatitis Patients Over Two Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05139836
• Other study ID #: P21-705
• Status: Recruiting
• Start date: December 13, 2021
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice.

Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years.

Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 772
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Body weight >=30 kg at baseline for participants between >=12 and <18 years of age.

• Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment.

• Upadacitinib initiated as per the local label. The decision to prescribe upadacitinib must have been made prior to and independently of study participation.

• Medical and medication history available at least for the last 6 months.

Exclusion Criteria:

• Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Germany	Hoeller-Obrigkeit, Aachen, DE /ID# 245430	Aachen
Germany	Petri, Ahaus, DE /ID# 243452	Ahaus
Germany	Dr. Stoeber /ID# 251066	Ahlen
Germany	Bell, Andernach, DE /ID# 249154	Andernach
Germany	Praxis Dr. Mihaescu /ID# 241825	Augsburg
Germany	MVZ medicum.mittelhessen /ID# 266126	Bad Camberg
Germany	Mauer, Bad Kreuznach, DE /ID# 241990	Bad Kreuznach
Germany	Timmel/Timm/Vorwerk, Bergen /ID# 241661	Bergen
Germany	Dre. Gellrich/Klein/Soost /ID# 250301	Berlin
Germany	Dues/Manasterski, Berlin, DE /ID# 243885	Berlin
Germany	Haut Pur - Dermatologische Gemeinschaftspraxis /ID# 243943	Berlin
Germany	Hautarztpraxis Dr. med. Christiane Handrick /ID# 262667	Berlin
Germany	Hautarztzentrum Tegel /ID# 241826	Berlin
Germany	Kors, Berlin, DE /ID# 241847	Berlin
Germany	Praxis Dermatologie am Savigny /ID# 248846	Berlin
Germany	Schirmer, Berlin, DE /ID# 241684	Berlin
Germany	Klinikum Rosenhoehe /ID# 241601	Bielefeld
Germany	Hautarztpraxis Dr. Weid /ID# 265213	Bingen am Rhein
Germany	Praxis fuer Innere Medizin/Rheumatologie /ID# 241846	Blaubeuren
Germany	Praxis T. Schadeck /ID# 241768	Bogen
Germany	Barth, Borna, DE /ID# 248871	Borna
Germany	Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 241658	Bramsche	Niedersachsen
Germany	Schwichtenberg, Bremen, DE /ID# 241683	Bremen
Germany	Praxis P. Hausler-Mehlhorn /ID# 241527	Chemnitz
Germany	Derma Köln /ID# 241856	Cologne
Germany	Dr. Hoffmann /ID# 245423	Cologne
Germany	Praxis Dr. Sbornik /ID# 241818	Deggendorf
Germany	Hautmedizin Delitzsch /ID# 251394	Delitzsch
Germany	Richter-Huhn, Dresden, DE /ID# 241822	Dresden
Germany	Praxis Dr. Korge /ID# 241531	Dueren
Germany	Praxis Dr. Mempel /ID# 241827	Elmshorn	Schleswig-Holstein
Germany	Praxis Dres. Freitag/Knoell /ID# 242278	Falkensee
Germany	Universitaetsklinikum Frankfurt /ID# 241766	Frankfurt am Main	Hessen
Germany	Praxis Dr. Hong-Weldemann /ID# 248844	Freiburg im Breisgau
Germany	Kurzen, Freising, DE /ID# 241845	Freising
Germany	Hautarztpraxis Friedberg Dr. med. Wilfried Jungkunz /ID# 248851	Friedberg (Hessen)
Germany	Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 241821	Gelsenkirchen
Germany	Rotterdam, Gelsenkirchen, DE /ID# 241819	Gelsenkirchen
Germany	Praxis Dr. Lange /ID# 241829	Gera
Germany	Loth, Gernsbach, DE /ID# 241828	Gernsbach
Germany	Hautarztpraxis Dr. Budihardja /ID# 241851	Gießen
Germany	Brinkmann & Partner, Gladbeck, /ID# 241850	Gladbeck
Germany	Dr. Krueger /ID# 265150	Goslar
Germany	Herrmann, Greifswald, DE /ID# 241889	Greifswald
Germany	Grossmann, Grossenhain, DE /ID# 250303	Grossenhain
Germany	Cutaneum /ID# 249104	Hamburg
Germany	Dermatologikum Hamburg /ID# 245431	Hamburg
Germany	Hautarztpraxis Luetten/Sack /ID# 241534	Hamburg
Germany	Praxis Dr. Kasche /ID# 249102	Hamburg
Germany	Praxis Dr. Wegener /ID# 263731	Hamburg
Germany	MVZ Prof. Dr. Ockenfels Haut- und Allergie-Praxisklinik GmbH /ID# 245395	Hanau
Germany	Praxis Dres. Kaspari /Schenck /ID# 241688	Hannover
Germany	Dr. Buerkle /ID# 250299	Haslach im Kinzigtal
Germany	Hautarztpraxis Haßberge /ID# 257648	Haßfurt
Germany	Durani & Durani, Heidelberg,DE /ID# 249172	Heidelberg
Germany	Universitaetsklinik Heidelberg /ID# 245834	Heidelberg	Baden-Wuerttemberg
Germany	Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 241908	Heilbad Heiligenstadt
Germany	Haut- u. Laserzentrum Heilbronn /ID# 250305	Heilbronn
Germany	Hausarztpraxis & Laserzentrum Dr. Zimmermann & Kollegen /ID# 251051	Heusenstamm
Germany	Praxis Dres. Bischoff/Danz /ID# 241852	Ilmenau
Germany	Stockmeier, Ingoldstadt, DE /ID# 248877	Ingolstadt
Germany	Hautarztpraxis Weidgang /ID# 248850	Juelich
Germany	Derma Sana /ID# 241854	Karlsruhe
Germany	Dermatologische Praxis Kempen /ID# 248852	Kempen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096	Kiel	Schleswig-Holstein
Germany	Dermatologie Kleinmachnow /ID# 268383	Kleinmachnow	Brandenburg
Germany	Grossmann, Koblenz, DE /ID# 242992	Koblenz
Germany	Praxis Dres. Bornemann/Reinerth /ID# 257649	Krefeld
Germany	Dres. Jacobs & Kollegen /ID# 241989	Kulmbach
Germany	Hautarztpraxis Langenau /ID# 242279	Langenau
Germany	Neubauer, Leipzig, DE /ID# 241823	Leipzig
Germany	Praxis Dres. Wiemers/Wiemers /ID# 241602	Leipzig
Germany	Haut- und Allergie-Zentrum Lippstadt /ID# 241929	Lippstadt
Germany	Hagemeier, Loehne, DE /ID# 241886	Loehne
Germany	Magdeburger Company for Medical Studies & Services GmbH /ID# 248849	Magdeburg
Germany	MVZ "Im Altstadtquartier" Magdeburg /ID# 261366	Magdeburg
Germany	Praxis Dr. Raschke /ID# 251398	Magdeburg
Germany	Universitaetsklinikum Magdeburg /ID# 249174	Magdeburg
Germany	Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 243325	Mainz
Germany	Hausärzte am Fastnachtsbrunnen /ID# 250304	Mainz
Germany	Hautarztpraxis Dr. Kirschner /ID# 266738	Mainz	Rheinland-Pfalz
Germany	Beldio Research GmbH /ID# 245830	Memmingen	Bayern
Germany	HMS GmbH Zimmer /ID# 241657	Merzig	Saarland
Germany	Praxis A. Viculova /ID# 266133	Miltenberg
Germany	Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 242280	Mölln	Schleswig-Holstein
Germany	ZENTderma /ID# 241539	Mönchengladbach
Germany	Dermatologie im Tal Praxis Dr.med. Maria Leibl /ID# 266128	Munich
Germany	Dermazent /Id# 268146	Munich	Bayern
Germany	Hautzentrum am Marienplatz /ID# 248847	Munich
Germany	Quack, Munich, DE /ID# 241536	Munich
Germany	Dr. Rezai /ID# 250298	Münster
Germany	Dr. Gißler-Walter /ID# 248876	Mutterstadt
Germany	Dermatologie im Apfelgarten /ID# 263704	Neu Wulmstorf
Germany	Praxis Dr. Konstantin Ertner /ID# 249153	Nuremberg
Germany	Voelkel, Nuremberg, DE /ID# 252445	Nuremberg
Germany	MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328	Oberursel
Germany	Hockmann, Oelde, DE /ID# 241906	Oelde
Germany	Praxis Dr. Behnke /ID# 248870	Panketal	Brandenburg
Germany	Hautärzte am Nauener Tor /ID# 261533	Potsdam	Brandenburg
Germany	Praxis Dr. Asadullah /ID# 243944	Potsdam	Brandenburg
Germany	Harzklinikum Dorothea Christiane Erxleben /ID# 251067	Quedlinburg
Germany	Kramer/Mortazawi, Remscheid /ID# 241824	Remscheid
Germany	Dr. Schaefers /ID# 255492	Reutlingen
Germany	Praxis Dr. Fränken /ID# 241853	Schwelm
Germany	CMS3 Company for Medical Study /ID# 241659	Selters	Rheinland-Pfalz
Germany	Haut- und Laserzentrum Hunsrück /ID# 243882	Simmern
Germany	Karl, Soest, DE /ID# 241909	Soest
Germany	Gemeinschaftspraxis fur Dermatologie /ID# 245831	Stadtroda
Germany	Flegl MD Stuttgart Germany /ID# 250302	Stuttgart
Germany	Praxis Dr. Termeer /ID# 241662	Stuttgart
Germany	Jasnoch/Kock/Borrosch, Vechta, /ID# 252081	Vechta
Germany	Barnikol, Waltershausen, DE /ID# 241844	Waltershausen
Germany	Praxis Dehmel / Brand-Opitzer /ID# 243884	Wasserburg A. Inn
Germany	Dr. Barbara Kempkes, Werne /ID# 241910	Werne
Germany	Dr. med. Nicola Möller & Thomas Kurtenbach GbR Dermatologie im Zentrum /ID# 266130	Wiesbaden
Germany	Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 241907	Witten
Germany	Albrecht, Wurzen, DE /ID# 241988	Wurzen

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Disease Control Defined by Atopic Dermatitis Control Tool (ADCT) Total Score <7 Points	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Month 3
Primary	Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points Among Participants Who Achieved Disease Control at Month 3	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Month 24
Secondary	Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Percentage of Participants with An ADCT Total Score Reduction >=5 from Baseline	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Percentage of Participants Achieving Disease Control as Defined by ADCT Item 4 (Sleep Problems) <1 Point and All Other Items <2 Points	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Percentage of Participants Achieving Disease Control as Defined by ADCT Total Score <7 Points at Month 3 and Maintaining Disease Control	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 21 Months (Excluding Month 3 - Primary Endpoint)
Secondary	Absolute Score for ADCT Total Score	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Absolute Change from Baseline for ADCT Total Score	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Time to Achieve ADCT Total Score Reduction >=5 Points from Baseline	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Time to Achieve Disease Control as Defined by ADCT Total Score <7 Points	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Percent Change from Baseline for ADCT Total Score	The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of >=7 indicates that the patient is not in control.	Up to 24 Months
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 50	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 75	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 90	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 100	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving Absolute EASI <=7	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Absolute Score for EASI	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Absolute Change from Baseline for EASI	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percent Change from Baseline for EASI	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Time to Achieve EASI 50	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Time to Achieve EASI 75	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Time to Achieve EASI 90	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Time to Achieve EASI 100	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Time to Achieve Absolute EASI <=7	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 50 in the Head and/or Neck Body Region	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 75 in the Head and/or Neck Body Region	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 90 in the Head and/or Neck Body Region	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving EASI 100 in the Head and/or Neck Body Region	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).	Up to 24 Months
Secondary	Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) <=1	vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.	Up to 24 Months
Secondary	Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) <=1	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Percentage of Participants Achieving WP-NRS <=3	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Percentage of Participants Achieving a WP-NRS Reduction >=4 from Baseline	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Absolute Score for WP-NRS	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Absolute Change from Baseline for WP-NRS	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Percent Change from Baseline for WP-NRS	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Time to Achieve WP-NRS <=1	WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.	Up to 24 Months
Secondary	Absolute Change from Baseline for SCORAD Sleep VAS	The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being "no sleeplessness" and 10 being "worst imaginable sleeplessness".	Up to 24 Months
Secondary	Absolute Score for Score Atopic Dermatitis (SCORAD) Sleep Visual Analog Scale (VAS)	The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being "no sleeplessness" and 10 being "worst imaginable sleeplessness".	Up to 24 Months
Secondary	Percent Change from Baseline for SCORAD Sleep VAS	The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being "no sleeplessness" and 10 being "worst imaginable sleeplessness".	Up to 24 Months
Secondary	Percentage of Participants Achieving Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (cDLQI) <=1	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Percentage of Participants Achieving DLQI/cDLQI <=5	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Percentage of Participants Achieving DLQI/cDLQI Reduction >=4 from Baseline	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Absolute Score for DLQI/cDLQI	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Absolute Change from Baseline for DLQI/cDLQI	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Percent Change from Baseline for DLQI/cDLQI	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Time to Achieve DLQI/cDLQI <=1	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.	Up to 24 Months
Secondary	Absolute Score for Hospital Anxiety and Depression Scale for Anxiety (HADS-A)	The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.	Up to 24 Months
Secondary	Absolute Change from Baseline for HADS-A	The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.	Up to 24 Months
Secondary	Percent Change from Baseline for HADS-A	The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.	Up to 24 Months
Secondary	Absolute Score for Hospital Anxiety and Depression Scale for Depression (HADS-D)	The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.	Up to 24 Months
Secondary	Absolute Change from Baseline for HADS-D	The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.	Up to 24 Months
Secondary	Percent Change from Baseline for HADS-D	The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.	Up to 24 Months
Secondary	Absolute Score for Stigmatization (6-Item Stigmatization Scale)	The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization.	Up to 24 Months
Secondary	Absolute Change from Baseline for Stigmatization (6-Item Stigmatization Scale)	The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization.	Up to 24 Months
Secondary	Percent Change from Baseline for Stigmatization (6-Item Stigmatization Scale)	The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization.	Up to 24 Months
Secondary	Absolute Score for Asthma Control Test (ACT) in Participants Having a Confirmed Diagnosis of Asthma at Baseline	The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.	Up to 24 Months
Secondary	Absolute Change from Baseline in ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline	The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.	Up to 24 Months
Secondary	Percent Change from Baseline in ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline	The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.	Up to 24 Months
Secondary	Percentage of Participants Achieving Absolute Score >=20 for ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline	The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.	Up to 24 Months
Secondary	Percentage of Participants Starting on Upadacitinib 15 mg or 30 mg	Percentage of participants initiating upadacitinib at 15 mg or 30 mg with rationale.	Baseline
Secondary	Percentage of Participants with Modification of Upadacitinib Therapy, Timing of Modifications, and Reasons for Modifications	This includes change in upadacitinib dose with rationale, e.g., dose change, temporary or permanent discontinuation.	24 Months
Secondary	Percentage of Participants with Modification of Concomitant AD Therapy, Timing of Modifications, and Reasons for Modifications	This includes change in concomitant AD therapy with rationale, e.g., adding or removing or changing dose of topical corticosteroids/topical calcineurin inhibitors.	24 Months
Secondary	Absolute Score for Skin Pain on the Atopic Dermatitis Symptom Scale (ADerm-SS)	Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".	Up to 24 Months
Secondary	Absolute Change from Baseline for Skin Pain on the ADerm-SS	Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".	Up to 24 Months
Secondary	Percent Change from Baseline for Skin Pain on the ADerm-SS	Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".	Up to 24 Months
Secondary	Absolute Score for Skin Cracking on the ADerm-SS	Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".	Up to 24 Months
Secondary	Absolute Change from Baseline for Skin Cracking on the ADerm-SS	Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".	Up to 24 Months
Secondary	Percent Change from Baseline for Skin Cracking on the ADerm-SS	Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".	Up to 24 Months
Secondary	Absolute Score for Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Hand Eczema	The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.	Up to 24 Months
Secondary	Absolute Change from Baseline for vIGA-AD of Hand Eczema	The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.	Up to 24 Months
Secondary	Percent Change from Baseline for vIGA-AD of Hand Eczema	The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.	Up to 24 Months
Secondary	Absolute Score for vIGA-AD of Facial Eczema	The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.	Up to 24 Months
Secondary	Absolute Change from Baseline for vIGA-AD of Facial Eczema	The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.	Up to 24 Months
Secondary	Percent Change from Baseline for vIGA-AD of Facial Eczema	The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.	Up to 24 Months
Secondary	Absolute Score for Pruritis (5-D Pruritis Scale)	The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis).	Up to 24 Months
Secondary	Absolute Change from Baseline for Pruritis (5-D Pruritis Scale)	The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis).	Up to 24 Months
Secondary	Percent Change from Baseline for Pruritis (5-D Pruritis Scale)	The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis).	Up to 24 Months
Secondary	Absolute Score for Flare Frequency	Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit.	Up to 24 Months
Secondary	Absolute Change from Baseline for Flare Frequency	Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit.	Up to 24 Months
Secondary	Percent Change from Baseline for Flare Frequency	Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit.	Up to 24 Months
Secondary	Absolute Score for Flare Duration	Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit.	Up to 24 Months
Secondary	Absolute Change from Baseline for Flare Duration	Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit.	Up to 24 Months
Secondary	Percent Change from Baseline for Flare Duration	Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit.	Up to 24 Months
Secondary	Absolute Score for Patient Self-Reported Global Assessment of Disease Severity (PtGA)	Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.	Up to 24 Months
Secondary	Absolute Change from Baseline for PtGA	Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.	Up to 24 Months
Secondary	Percent Change from Baseline for PtGA	Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.	Up to 24 Months
Secondary	Percentage of Participants Achieving PtGA <=2	Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.	Up to 24 Months
Secondary	Percentage of Participants Achieving PtGA Reduction >=1 from Baseline	Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.	Up to 24 Months
Secondary	Incidence and Type of Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug but within 30 days after the last dose of study drug.	Up to 24 Months

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