A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— Level Up  

Official title:

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05601882
• Other study ID #: M23-696
• Secondary ID: 2022-002482-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 28, 2022
• Est. completion date: July 9, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 880
• Est. completion date: July 9, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 64 Years

Eligibility

Inclusion Criteria:

• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.

• Eczema area and severity index (EASI) score = 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score = 3 and = 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.

• Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) = 4.

• Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

Exclusion Criteria:

• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

• History of an organ transplant which requires continued immunosuppression.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Upadacitinib
Oral Tablets
• Dupilumab
Subcutaneous Injection

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc /ID# 249938	Carlton	Victoria
Australia	Sinclair Dermatology - Melbourne /ID# 249937	East Melbourne	Victoria
Australia	Fremantle Dermatology /ID# 249941	Fremantle	Western Australia
Australia	Premier Specialist /ID# 250572	Kogarah	New South Wales
Australia	Veracity Clinical Research /ID# 249943	Woolloongabba	Queensland
Belgium	Grand Hopital de Charleroi /ID# 251401	Charleroi	Hainaut
Belgium	Universitair Ziekenhuis Leuven /ID# 251399	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 251400	Liege
Belgium	Cliniques Universitaires UCL Saint-Luc /ID# 251403	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 251268	Pleven
Bulgaria	DCC Pulmed AD /ID# 251271	Plovdiv
Bulgaria	ASMC-IPSMC-Skin and Venereal Diseases /ID# 251272	Sofia
Bulgaria	Medical center EuroHealth /ID# 251270	Sofia
Bulgaria	Military Medical Academy Multiprofile Hospital /ID# 251187	Sofia
Bulgaria	Diagnostic Consultative Center Aleksandrovska /ID# 251137	Sofiya	Sofia
Bulgaria	Diagnostic consultative center Focus-5 /ID# 251269	Sofiya
Bulgaria	Medical Center Euroderma /ID# 251267	Sofiya
Bulgaria	MC Zara-Med EOOD /ID# 251135	Stara Zagora
Canada	Beacon Dermatology Inc /ID# 250336	Calgary	Alberta
Canada	Dermatology Research Institute - Blackfoot Trail /ID# 251642	Calgary	Alberta
Canada	Alberta DermaSurgery Centre /ID# 250217	Edmonton	Alberta
Canada	Brunswick Dermatology Center /ID# 250220	Fredericton	New Brunswick
Canada	LEADER Research /ID# 251647	Hamilton	Ontario
Canada	DermEffects /ID# 250223	London	Ontario
Canada	Lynde Institute for Dermatology /ID# 251854	Markham	Ontario
Canada	DermEdge Research Inc. /ID# 250216	Mississauga	Ontario
Canada	SKiN Centre for Dermatology /ID# 251853	Peterborough	Ontario
Canada	Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427	Québec	Quebec
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 251643	Surrey	British Columbia
Canada	Enverus Medical Research /ID# 251645	Surrey	British Columbia
Canada	Research Toronto /ID# 250222	Toronto	Ontario
Canada	Toronto Dermatology Centre /ID# 252098	Toronto	Ontario
Canada	Private Practice - Dr. Kim Papp Clinical Research /ID# 251644	Waterloo	Ontario
Canada	Wiseman Dermatology Research /ID# 250219	Winnipeg	Manitoba
China	The Second Xiangya Hospital of Central South University /ID# 249657	Changsha
China	The First Affiliated Hospital Of Fujian Medical University /ID# 249674	Fuzhou	Fujian
China	Dermatology Hospital of Southern Medical University /ID# 250121	Guangzhou	Guangdong
China	Guangzhou First People's Hospital /ID# 249695	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694	Guangzhou	Guangdong
China	Hangzhou First People's Hospital /ID# 249437	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 249655	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital /ID# 249653	Hangzhou	Zhejiang
China	Huashan Hospital, Fudan University /ID# 250025	Shanghai	Shanghai
China	Shanghai Skin Disease Hospital /ID# 249392	Shanghai	Shanghai
China	The First Hospital of China Medical University /ID# 249638	Shenyang	Liaoning
China	The University of Hong Kong- Shenzhen Hospital /ID# 249436	Shenzhen	Guangdong
China	Tianjin Medical University General Hospital /ID# 250246	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485	Wuhan	Hubei
Croatia	Poliklinika Solmed /ID# 252138	Grad Zagreb
Croatia	Klinicki bolnicki centar Rijeka /ID# 249593	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 249879	Split	Splitsko-dalmatinska Zupanija
Croatia	DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591	Zagreb	Grad Zagreb
Croatia	Djecja bolnica Srebrnjak /ID# 249594	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 249596	Zagreb	Grad Zagreb
Croatia	Klinika za djecje bolesti Zagreb /ID# 249590	Zagreb	Grad Zagreb
Denmark	Aarhus Universitetshospital - Skejby /ID# 248899	Aarhus	Midtjylland
Denmark	Bispebjerg and Frederiksberg Hospital /ID# 248902	Copenhagen NV	Hovedstaden
Denmark	Herlev and Gentofte Hospital /ID# 248900	Hellerup	Hovedstaden
Denmark	Roskilde Sygehus /ID# 248901	Roskilde	Sjælland
France	Hopital Saint Joseph /ID# 251053	Marseille	Bouches-du-Rhone
France	CHU de Nantes, Hotel Dieu -HME /ID# 251347	Nantes	Pays-de-la-Loire
France	AP-HP - Hopital Saint-Louis /ID# 251052	Paris
France	HCL - Hopital Lyon Sud /ID# 251343	Pierre Benite CEDEX	Rhone
France	Hôpital Charles-Nicolle /ID# 251055	Rouen
France	CHU Toulouse - Hopital Larrey /ID# 251344	Toulouse
Germany	Fachklinik Bad Bentheim /ID# 249545	Bad Bentheim
Germany	Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306	Blankenfelde-Mahlow	Brandenburg
Germany	Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566	Bochum
Germany	Universitaetsklinikum Bonn /ID# 250307	Bonn
Germany	Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392	Bramsche	Niedersachsen
Germany	Klinikum Darmstadt - Grafenstrasse /ID# 251391	Darmstadt	Hessen
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844	Dresden
Germany	Universitaetsklinikum Frankfurt /ID# 249544	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Freiburg /ID# 249555	Freiburg	Baden-Wuerttemberg
Germany	Derma Study Center Friedrichshafen GmbH /ID# 251460	Friedrichshafen
Germany	Dermatologikum Hamburg /ID# 251390	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf /ID# 249547	Hamburg
Germany	Universitaetsklinik Heidelberg /ID# 251458	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Leipzig /ID# 249562	Leipzig	Sachsen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560	Lübeck	Schleswig-Holstein
Germany	Universitaetsmedizin Mainz /ID# 249549	Mainz	Rheinland-Pfalz
Germany	Universitaetsklinikum Muenster /ID# 249404	Muenster	Nordrhein-Westfalen
Germany	Klinikum rechts der Isar /ID# 249548	Munich
Germany	Universitaetsklinikum Tuebingen /ID# 249552	Tubingen	Baden-Wuerttemberg
Greece	401 GSNA - 401 Army General Hospital /ID# 251843	Athens	Attiki
Greece	General Hospital Andreas Syggros /ID# 251842	Athens	Attiki
Greece	Papageorgiou General Hospital /ID# 251840	Thessaloniki
Hungary	Clinexpert Kft /ID# 249822	Budapest
Hungary	Semmelweis Egyetem /ID# 251368	Budapest
Hungary	UNO Medical Trials /ID# 249820	Budapest
Hungary	Debreceni Egyetem-Klinikai Kozpont /ID# 249849	Debrecen	Hajdu-Bihar
Hungary	DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 249819	Debrecen
Hungary	Gyongyosi Bugat Pal Korhaz /ID# 251367	Gyongyos	Heves
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848	Kaposvár	Somogy
Hungary	Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850	Kecskemet
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419	Pecs
Hungary	Szegedi Tudományegyetem /ID# 249818	Szeged
Hungary	Allergo-Derm Bakos Kft. /ID# 249821	Szolnok
Israel	Rabin Medical Center /ID# 251578	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 251576	Jerusalem	Yerushalayim
Italy	ASST Spedali civili di Brescia /ID# 250129	Brescia
Italy	CAST - Center for Advanced Studies and Technology /ID# 251495	Chieti
Italy	Ospedale Piero Palagi /ID# 250206	Florence
Italy	Presidio Ospedaliero San Salvatore /ID# 250127	L'Aquila	L Aquila
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123	Milan
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 250128	Modena
Italy	Azienda Ospedaliera di Perugia /ID# 251572	Perugia	Umbria
Italy	Azienda Ospedaliero Universitaria Pisana /ID# 250124	Pisa
Italy	Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494	Roma
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125	Rome	Roma
Italy	IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 251493	Rozzano	Milano
Japan	Osaka Habikino Medical Center /ID# 252550	Habikino-shi	Osaka
Japan	Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554	Kawasaki-shi	Kanagawa
Japan	National Hospital Organization Sagamihara National Hospital /ID# 254518	Sagamihara-shi	Kanagawa
Japan	Dermatology and Ophthalmology Kume Clinic /ID# 254570	Sakai-shi	Osaka
Japan	Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549	Sapporo-shi	Hokkaido
Japan	Naoko Dermatology Clinic /ID# 254571	Setagaya-ku	Tokyo
Japan	Queen's Square Medical Center, Dermatology and Allergology /ID# 252551	Yokohama-shi	Kanagawa
Korea, Republic of	Kyungpook National University Hospital /ID# 249855	??	Daegu Gwang Yeogsi
Korea, Republic of	Korea University Ansan Hospital /ID# 249814	Ansan-si	Gyeonggido
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon /ID# 249812	Bucheon-si	Gyeonggido
Korea, Republic of	Pusan National University Hospital /ID# 249852	Busan
Korea, Republic of	Chungang University Hospital /ID# 251490	Dongjak-gu	Gyeonggido
Korea, Republic of	Konkuk University Medical Center /ID# 249811	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 251492	Seoul
Korea, Republic of	Ajou University Hospital /ID# 251491	Suwon-si	Gyeonggido
Mexico	Cryptex Investigacion Clinica S.A de C.V /ID# 249994	Mexico City
Mexico	Centro de Dermatologia de Monterrey /ID# 249126	Monterrey
Mexico	Eukarya PharmaSite, SC /ID# 249702	Monterrey	Nuevo Leon
Mexico	Clinical Research Institute SC /ID# 249647	Tlalnepantla de Baz
Mexico	Arké Estudios Clinicos Veracruz /ID# 250147	Veracruz
Netherlands	Academisch Medisch Centrum /ID# 251397	Amsterdam	Noord-Holland
Netherlands	Bravis Ziekenhuis /ID# 251395	Bergen op Zoom	Noord-Brabant
Poland	INTER CLINIC Piotr Adrian Klimiuk /ID# 251430	Bialystok	Podlaskie
Poland	Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630	Cracow
Poland	Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082	Cracow	Malopolskie
Poland	Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438	Elblag	Warminsko-mazurskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431	Gdansk	Pomorskie
Poland	Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598	Iwonicz-Zdrój	Podkarpackie
Poland	Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437	Krakow	Malopolskie
Poland	Dermed Centrum Medyczne Sp. z o.o /ID# 251429	Lodz	Lodzkie
Poland	Solumed Centrum Medyczne /ID# 249641	Poznan	Wielkopolskie
Poland	Nasz Lekarz Przychodnie Medyczne /ID# 251433	Torun	Kujawsko-pomorskie
Poland	Royalderm Agnieszka Nawrocka /ID# 251432	Warsaw	Mazowieckie
Poland	Bodyclinic Sp. z o.o. sp.k. /ID# 249599	Warszawa	Mazowieckie
Poland	Klinika Ambroziak Sp. z o.o. /ID# 249406	Warszawa	Mazowieckie
Portugal	Hospital Garcia de Orta /ID# 251455	Almada	Setubal
Portugal	2CA-Braga, Hospital de Braga /ID# 250480	Braga
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196	Guimaraes	Braga
Portugal	Unidade Local de Saude da Regiao de Leiria, EPE /ID# 249194	Leiria
Portugal	Hospital CUF Descobertas /ID# 249193	Lisboa
Portugal	Centro Hospitalar de Lisboa Central /ID# 249195	Lisbon
Portugal	Unidade Local de Saúde de Matosinhos, EPE /ID# 249197	Matosinhos
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192	Porto
Portugal	Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191	Porto
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 250389	Caguas
Puerto Rico	Alma M. Cruz Santana, MD-Private practice /ID# 250393	Carolina
Puerto Rico	Clinical Research Puerto Rico /ID# 250394	San Juan
Puerto Rico	GCM Medical Group PSC /ID# 250391	San Juan
Romania	Bio Terra Med SRL /ID# 249624	Bucharest	Bucuresti
Romania	Private Practice - Dr. Orasan Remus /ID# 249625	Cluj Napoca	Cluj
Slovakia	BeneDerma s.r.o. /ID# 251791	Bratislava
Slovakia	Derma therapy spol /ID# 249783	Bratislava	Bratislavsky Kraj
Slovakia	Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746	Bratislava
South Africa	Allergy & Immunology (AIU) /ID# 249619	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 250091	CAPE TOWN Milnerton	Western Cape
South Africa	Highway Medical Centre /ID# 250103	Durban	Kwazulu-Natal
South Africa	About Allergy /ID# 249697	Pretoria	Gauteng
South Africa	University of Pretoria /ID# 250208	Pretoria	Gauteng
Spain	Hospital General Universitario de Alicante Doctor Balmis /ID# 251517	Alicante
Spain	Hospital Universitario Germans Trias i Pujol /ID# 251523	Badalona	Barcelona
Spain	Hospital Universitario Basurto /ID# 249784	Bilbao	Vizcaya
Spain	Hospital Sant Joan de Deu /ID# 249602	Esplugues de Llobregat	Barcelona
Spain	Hospital Universitario Virgen de las Nieves /ID# 249785	Granada
Spain	Hospital Universitario La Paz /ID# 251518	Madrid
Spain	Hospital Universitario Virgen Macarena /ID# 249603	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 251524	Valencia
Sweden	Malarsjukhuset /ID# 251908	Eskilstuna
Sweden	Skane University hospital /ID# 250332	Malmo	Skane Lan
Sweden	Karolinska University Hospital Solna /ID# 250328	Solna	Stockholms Lan
Sweden	Norrlands University hospital /ID# 250329	Umea	Vasterbottens Lan
Switzerland	Inselspital, Universitaetsspital Bern /ID# 250577	Bern
Switzerland	Kantonsspital St. Gallen /ID# 250606	St. Gallen	Sankt Gallen
Taiwan	National Taiwan University Hospital - Hsinchu branch /ID# 249265	Hsinchu City
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 249260	Kaohsiung City	Kaohsiung
Taiwan	Taipei Medical University Shuang Ho Hospital /ID# 249256	New Taipei City
Taiwan	Taichung Veterans General Hospital /ID# 249261	Taichung
Taiwan	Taipei Municipal Wan Fang Hospital /ID# 251500	Taipei
Taiwan	Taipei Veterans General Hosp /ID# 249263	Taipei
Taiwan	Mackay Memorial Hospital /ID# 249259	Taipei City	Taipei
Taiwan	National Taiwan University Hospital /ID# 249258	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 249257	Taoyuan City
Turkey	Ankara City Hospital /ID# 249870	Ankara
Turkey	Akdeniz Universitesi Tip Fakul /ID# 249866	Antalya
Turkey	Uludag University Medical Faculty /ID# 249864	Bursa
Turkey	Gaziantep Universitesi /ID# 249868	Gaziantep
Turkey	Erciyes University Medical Faculty /ID# 249863	Kayseri
Turkey	Ondokuz Mayis Universitesi Tip /ID# 249865	Samsun
United States	Arlington Research Center, Inc /ID# 250468	Arlington	Texas
United States	Orion Clinical Research /ID# 250473	Austin	Texas
United States	Bellaire Dermatology Associates /ID# 250739	Bellaire	Texas
United States	Derm of Greater Columbus /ID# 250049	Bexley	Ohio
United States	Clearlyderm Dermatology /ID# 250457	Boca Raton	Florida
United States	Skin Care Research Boca Raton /ID# 250458	Boca Raton	Florida
United States	Treasure Valley Medical Research /ID# 250727	Boise	Idaho
United States	Beth Israel Deaconess Medical Center /ID# 251212	Boston	Massachusetts
United States	Montefiore Medical Center - Moses Campus /ID# 251214	Bronx	New York
United States	Duplicate_Medical University of South Carolina /ID# 251218	Charleston	South Carolina
United States	University of Virginia - Dermatology /ID# 254166	Charlottesville	Virginia
United States	Clarkston Dermatology /ID# 250225	Clarkston	Michigan
United States	Olympian Clinical Research /ID# 250453	Clearwater	Florida
United States	Univ Hosp Cleveland /ID# 250699	Cleveland	Ohio
United States	Modern Research Associates, PLLC /ID# 250688	Dallas	Texas
United States	Henry Ford Medical Center - New Center One /ID# 250228	Detroit	Michigan
United States	Joseph Raoof Md,Inc /Id# 250211	Encino	California
United States	Wright State Physicians - Fairborn /ID# 254167	Fairborn	Ohio
United States	UConn Health /ID# 253807	Farmington	Connecticut
United States	Clinical Trials Institute - Northwest Arkansas /ID# 249838	Fayetteville	Arkansas
United States	First OC Dermatology /ID# 250686	Fountain Valley	California
United States	Skin Care Research - Hollywood /ID# 250459	Hollywood	Florida
United States	Center for Clinical Studies - Houston - Northwest Freeway /ID# 250039	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 250276	Indianapolis	Indiana
United States	Solutions Through Adv Rch /ID# 250455	Jacksonville	Florida
United States	Cleaver Dermatology /ID# 250725	Kirksville	Missouri
United States	Antelope Valley Clinical Trials /ID# 249946	Lancaster	California
United States	Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616	Lincoln	Nebraska
United States	Physician Research Collaboration, LLC /ID# 251099	Lincoln	Nebraska
United States	Dermatology Research Associates /ID# 249829	Los Angeles	California
United States	GSI Clinical Research, LLC /ID# 250768	Margate	Florida
United States	D&H National Research Centers /ID# 250734	Miami	Florida
United States	Florida International Rsrch cr /ID# 249667	Miami	Florida
United States	Wellness Clinical Research - Miami Lakes /ID# 250236	Miami Lakes	Florida
United States	International Clinical Research - Tennessee LLC /ID# 250724	Murfreesboro	Tennessee
United States	University of Utah /ID# 250042	Murray	Utah
United States	Yale Center for Clinical Investigation /ID# 254791	New Haven	Connecticut
United States	Virginia Clinical Research, Inc. /ID# 249908	Norfolk	Virginia
United States	Arkansas Research Trials /ID# 250722	North Little Rock	Arkansas
United States	Tory P Sullivan, MD PA /ID# 251136	North Miami Beach	Florida
United States	Alliance Dermatology and MOHs Center, PC /ID# 249671	Phoenix	Arizona
United States	Medical Dermatology Specialists /ID# 250212	Phoenix	Arizona
United States	University of Pittsburgh MC /ID# 251208	Pittsburgh	Pennsylvania
United States	Oregon Dermatology and Research Center /ID# 250726	Portland	Oregon
United States	Oregon Medical Research Center /ID# 249666	Portland	Oregon
United States	Oregon Medical Research Center /ID# 250712	Portland	Oregon
United States	Beacon Clinical Research, LLC /ID# 251412	Quincy	Massachusetts
United States	Health Concepts /ID# 250988	Rapid City	South Dakota
United States	University of California Davis Health /ID# 250044	Sacramento	California
United States	MediSearch Clinical Trials /ID# 250272	Saint Joseph	Missouri
United States	Texas Dermatology and Laser Specialists /ID# 250367	San Antonio	Texas
United States	Precision Clinical Research /ID# 250990	Sunrise	Florida
United States	Advanced Clinical Research Institute /ID# 250460	Tampa	Florida
United States	Clinical Trials Research Institute /ID# 250213	Thousand Oaks	California
United States	Vital Prospects Clinical Research Institute, PC /ID# 249840	Tulsa	Oklahoma
United States	Randall Dermatology of West Lafayette /ID# 250234	West Lafayette	Indiana
United States	Metabolic Research Inst /ID# 250046	West Palm Beach	Florida
United States	Western States Clinical Res /ID# 250274	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Croatia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Romania,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	At week 16
Secondary	Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.	Up to week 16
Secondary	Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1	The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	Up to week 16
Secondary	Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) = 4 among those with Baseline WP-NRS = 4	The WP-NRS is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	At week 16
Secondary	Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.	At week 2
Secondary	Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72.	At week 16

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