Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195698
• Other study ID #: M19-850
• Secondary ID: 2019-001227-12
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2020
• Est. completion date: September 11, 2023

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.

• Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

• Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.

• Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Upadacitinib
Upadacitinib will be administered oral as tablet

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice /ID# 218755	Darlinghurst	New South Wales
Australia	The Skin Hospital /ID# 218753	Darlinghurst	New South Wales
Australia	Sinclair Dermatology /ID# 218751	East Melbourne	Victoria
Australia	Burswood Dermatology /ID# 218752	Victoria Park	Western Australia
Australia	Veracity Clinical Research /ID# 218754	Woolloongabba	Queensland
Canada	Dermatology Research Institute Inc. /ID# 218728	Calgary	Alberta
Canada	Kirk Barber Research, CA /ID# 218727	Calgary	Alberta
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 218722	London	Ontario
Canada	Lynderm Research Inc. /ID# 218723	Markham	Ontario
Canada	DermEdge Research Inc. /ID# 218721	Mississauga	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 218724	Saint-Jerome	Quebec
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 218725	Surrey	British Columbia
Canada	Enverus Medical Research /ID# 218726	Surrey	British Columbia
Canada	North York Research Inc /ID# 218729	Toronto	Ontario
Canada	K. Papp Clinical Research /ID# 218730	Waterloo	Ontario
Croatia	Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376	Ivanic-Grad	Zagrebacka Zupanija
Croatia	DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 218375	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Hradec Kralove /ID# 214176	Hradec Kralove
Czechia	Nemocnice Jihlava, prispevkova organizace /ID# 214178	Jihlava
Czechia	Fakultni nemocnice Ostrava /ID# 214177	Ostrava
Czechia	Fakultni Nemocnice v Motole /ID# 214179	Praha
Finland	Keski-pohjanmaa Central Hospital /ID# 214630	Kokkola	Keski-Pohjanmaa
Finland	Mikkeli Central Hospital /ID# 214629	Mikkeli
Finland	Oulun yliopistollinen sairaala /ID# 214628	Oulu	Pohjois-Pohjanmaa
France	AP-HM - Hopital de la Timone /ID# 218957	Marseille CEDEX 05	Bouches-du-Rhone
France	CHU de Nantes, Hotel Dieu -HME /ID# 218959	Nantes	Pays-de-la-Loire
France	Polyclinique Courlancy /ID# 218955	Reims	Marne
France	Hôpital Charles-Nicolle /ID# 218960	Rouen
France	CHU Toulouse - Hopital Larrey /ID# 218958	Toulouse
Germany	Klinikum Darmstadt /ID# 214224	Darmstadt
Germany	Universitaetsklinikum Frankfurt /ID# 214223	Frankfurt am Main	Hessen
Germany	Medizinische Hochschule Hannover /ID# 214226	Hannover
Germany	Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225	Mahlow
Germany	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221	Munich
Germany	Universitaetsklinikum Muenster /ID# 214222	Munster	Niedersachsen
Hungary	Uno Medical Trials Kft /ID# 214987	Budapest
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984	Kaposvár	Somogy
Hungary	Oroshazi Korhaz /ID# 214986	Oroshaza	Bekes
Ireland	St Vincent's University Hospital /ID# 213558	Elm Park	Dublin
Israel	HaEmek Medical Center /ID# 218520	Afula
Israel	Rabin Medical Center /ID# 218521	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 218522	Ramat Gan	Tel-Aviv
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095	Milan
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 214096	Modena
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 214093	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 215727	Rozzano	Milano
Malaysia	Hospital Sultan Ismail /ID# 218881	Johor Bahru	Johor
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879	Kuala Lumpur	Selangor
Malaysia	University Malaya Med Ctr /ID# 218882	Kuala Lumpur
Malaysia	Hospital Pakar Sultanah Fatimah /ID# 218877	Muar	Johor
Malaysia	Hospital Pulau Pinang /ID# 218878	Penang
Malaysia	Hospital Putrajaya /ID# 218880	Putrajaya	Wilayah Persekutuan Putrajaya
Netherlands	Bravis Ziekenhuis /ID# 218772	Bergen op Zoom	Noord-Brabant
Netherlands	Universitair Medisch Centrum Groningen /ID# 218775	Groningen
Netherlands	Erasmus Medisch Centrum /ID# 218770	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht /ID# 218771	Utrecht
New Zealand	Optimal Clinical Trials Ltd /ID# 218688	Grafotn	Auckland
New Zealand	Clinical Trials NZ /ID# 218690	Hamilton
New Zealand	Wellington Regional Hospital /ID# 218689	Newtown	Wellington
Norway	Universitetssykehuset N-Norge, Tromso /ID# 214634	Tromso	Troms
Poland	ClinicMed Daniluk, Nowak Sp.k. /ID# 214299	Bialystok	Podlaskie
Poland	Pratia MCM Krakow /ID# 214303	Krakow	Malopolskie
Poland	Dermoklinika Centrum Medyczne s.c. /ID# 214300	Lodz	Lodzkie
Poland	Klinika Ambroziak Sp. z o.o. /ID# 214301	Warszawa	Mazowieckie
Poland	Royalderm Agnieszka Nawrocka /ID# 214302	Warszawa	Mazowieckie
Singapore	National University Hospital /ID# 219093	Singapore
Spain	Hospital Universitario de Bellvitge /ID# 214257	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Dr. Negrin /ID# 214256	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital de Manises /ID# 214258	Manises	Valencia
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 214255	Pontevedra
Spain	Hospital Universitario Arnau Vilanova /ID# 214254	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 214252	Valencia
Taiwan	China Medical University Hospital /ID# 218409	Taichung
Taiwan	Chung Shan Medical University Hospital /ID# 218919	Taichung
Taiwan	Taipei Municipal Wan Fang Hospital /ID# 218918	Taipei
Taiwan	National Taiwan University Hospital /ID# 218917	Taipei City
Ukraine	Kyiv City Clinical Skin and Venereal Hospital /ID# 218382	Kyiv	Kyivska Oblast
Ukraine	ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385	Rivne
United Kingdom	NHS Greater Glasgow and Clyde /ID# 213561	Glasgow	Scotland
United Kingdom	Victoria Hospital /ID# 213564	Kirkcaldy	Fife
United Kingdom	The Royal Free London NHS Foundation Trust /ID# 213560	London	London, City Of
United Kingdom	University Hospitals Sussex NHS Foundation Trust /ID# 213562	Worthing
United States	Georgia Pollens Clinical Research Centers, Inc /ID# 218441	Albany	Georgia
United States	Orion Clinical Research /ID# 218565	Austin	Texas
United States	Medical University of South Carolina /ID# 221072	Charleston	South Carolina
United States	Medical Dermatology Associates of Chicago /ID# 218551	Chicago	Illinois
United States	Michigan Center for Research Company /ID# 218577	Clarkston	Michigan
United States	University Hospitals Case Medical Center /ID# 218574	Cleveland	Ohio
United States	Henry Ford Medical Center /ID# 218575	Detroit	Michigan
United States	First OC Dermatology Research Inc /ID# 218619	Fountain Valley	California
United States	UCSF Fresno /ID# 218453	Fresno	California
United States	Dawes Fretzin, LLC /ID# 218478	Indianapolis	Indiana
United States	Clinical Research Solutions, LLC /ID# 218447	Jackson	Tennessee
United States	Sante Clinical Research /ID# 218911	Kerrville	Texas
United States	Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548	Lincoln	Nebraska
United States	University of Arkansas for Medical Sciences /ID# 221021	Little Rock	Arkansas
United States	California Allergy and Asthma Medical Group /ID# 218635	Los Angeles	California
United States	Dermatology Research Associates /ID# 218637	Los Angeles	California
United States	Florida International Rsrch cr /ID# 218663	Miami	Florida
United States	Miami Dermatology and Laser Institute /ID# 218664	Miami	Florida
United States	Dermatology Clinical Trials /ID# 218627	Newport Beach	California
United States	Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552	Normal	Illinois
United States	Skin Specialists, PC /ID# 218549	Omaha	Nebraska
United States	Oregon Medical Res Center PC /ID# 218440	Portland	Oregon
United States	Oregon Medical Research Center /ID# 218578	Portland	Oregon
United States	Beacon Clinical Research, LLC /ID# 218636	Quincy	Massachusetts
United States	Clinical Research Partners, LLC /ID# 218480	Richmond	Virginia
United States	UC Davis Health /ID# 218582	Sacramento	California
United States	GCP Research /ID# 218665	Saint Petersburg	Florida
United States	Ucsd /Id# 218629	San Diego	California
United States	Clinical Science Institute /ID# 218632	Santa Monica	California
United States	West Virginia Research Inst /ID# 218479	South Charleston	West Virginia
United States	Premier Clinical Research /ID# 218583	Spokane	Washington
United States	Clinical Research Trials of Florida, Inc. /ID# 218438	Tampa	Florida
United States	Southside Dermatology /ID# 218477	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Croatia,  Czechia,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Malaysia,  Netherlands,  New Zealand,  Norway,  Poland,  Singapore,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.	From Baseline to 30 days following last dose of study drug (Week 52)

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.