A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Launched by ABBVIE · Nov 9, 2018
Trial Information
Current as of May 17, 2025
Completed
Keywords
ClinConnect Summary
The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks.
Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale f...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- • Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.
- Exclusion Criteria:
- • Participant has prior exposure to Janus Kinase (JAK) inhibitor.
- • Participant has prior exposure to dupilumab.
- • Participant is unable or unwilling to discontinue current AD treatments prior to the study.
- • Participant has requirement of prohibited medications during the study.
- • Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
- • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Fresno, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
Santa Monica, California, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Port Orange, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Albany, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Normal, Illinois, United States
Indianapolis, Indiana, United States
Quincy, Massachusetts, United States
Clarkston, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Bronx, New York, United States
Kew Gardens, New York, United States
Winston Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Jackson, Tennessee, United States
Austin, Texas, United States
Bryan, Texas, United States
Fort Worth, Texas, United States
Kerrville, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Spokane, Washington, United States
South Charleston, West Virginia, United States
Darlinghurst, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Woolloongabba, Queensland, Australia
East Melbourne, Victoria, Australia
Victoria Park, Western Australia, Australia
Calgary, Alberta, Canada
Calgary, Alberta, Canada
Surrey, British Columbia, Canada
Surrey, British Columbia, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Saint Jerome, Quebec, Canada
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Ivanic Grad, Zagrebacka Zupanija, Croatia
Brno, , Czechia
Hradec Kralove, , Czechia
Jihlava, , Czechia
Ostrava, , Czechia
Praha, , Czechia
Kokkola, Keski Pohjanmaa, Finland
Oulu, Pohjois Pohjanmaa, Finland
Mikkeli, , Finland
Turku, , Finland
Lille Cedex, Hauts De France, France
Nantes Cedex 1, Pays De La Loire, France
Rouen Cedex, Seine Maritime, France
Marseille, , France
Nice, , France
Reims, , France
Toulouse, , France
Munster, Niedersachsen, Germany
Blankenfeld Mahlow, , Germany
Darmstadt, , Germany
Frankfurt, , Germany
Hannover, , Germany
Munich, , Germany
Oroshaza, Bekes, Hungary
Budapest Xiii, , Hungary
Debrecen, , Hungary
Kaposvar, , Hungary
Pecs, , Hungary
Dublin, , Ireland
Waterford, , Ireland
Afula, , Israel
Petakh Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Milan, Lombardia, Italy
Rozzano, Milano, Italy
Bologna, , Italy
Brescia, , Italy
Cagliari, , Italy
Modena, , Italy
Rome, , Italy
Johor Bahru, Johor, Malaysia
Muar, Johor, Malaysia
Kuala Lumpur, Selangor, Malaysia
Kuala Lumpur, , Malaysia
Penang, , Malaysia
Putrajaya, , Malaysia
Bergen Op Zoom, Noord Brabant, Netherlands
Amsterdam, Noord Holland, Netherlands
Alkmaar, , Netherlands
Groningen, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Auckland, , New Zealand
Hamilton, , New Zealand
Wellington, , New Zealand
Trondheim, Sor Trondelag, Norway
Harstad, Troms, Norway
Tromso, Troms, Norway
Bydgoszcz, Kujawsko Pomorskie, Poland
Lodz, Lodzkie, Poland
Krakow, Malopolskie, Poland
Warsaw, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Singapore, Central Singapore, Singapore
Singapore, , Singapore
Singapore, , Singapore
L'hospitalet De Llobregat, Barcelona, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Manises, Valencia, Spain
Pontevedra, , Spain
Valencia, , Spain
Valencia, , Spain
Malmö, Skane Lan, Sweden
Stockholm, , Sweden
Taichung City, Taichung, Taiwan
Taipei City, Taipei, Taiwan
Taichung City, , Taiwan
Taipei, , Taiwan
Zaporizhzhya, Zaporizka Oblast, Ukraine
Kyiv, , Ukraine
Rivne, , Ukraine
Brighton, Brighton And Hove, United Kingdom
Kirkcaldy, Fife, United Kingdom
Glasgow, Glasgow City, United Kingdom
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Cardiff, Wales, United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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