A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Launched by ABBVIE · Jun 14, 2018
Trial Information
Current as of November 15, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study tested how well the oral medicine upadacitinib works when added to topical corticosteroids for adults and teens with moderate-to-severe atopic dermatitis (eczema). It included people aged 12–75 who had active disease (EASI score 16 or higher, a vIGA-AD score of 3 or 4, 10% or more body skin affected, and weekly itching (NRS) of 4 or more) and who had not responded adequately to standard skin creams or had recent systemic treatment. Participants were randomly assigned to one of three groups for 16 weeks: upadacitinib 15 mg daily plus topical steroids, upadacitinib 30 mg daily plus topical steroids, or placebo daily plus topical steroids. After week 16, some participants could be re-randomized to receive upadacitinib in a blinded extension, with long-term follow-up planned.
Results at Week 16 showed substantial benefit with upadacitinib, especially at the 30 mg dose. In adults, about 65% of those on 15 mg and 77% on 30 mg achieved at least a 75% reduction in eczema symptoms (EASI75) versus about 26% on placebo, and a majority reached clear or almost-clear skin (vIGA-AD 0/1). Teens showed similar patterns: roughly two-thirds to nearly all in the upadacitinib groups reached EASI75 by week 16, compared with about 30% on placebo. Improvements were also seen in other measures of disease and itching, with greater effect at the higher dose. Safety was monitored closely; adverse events and infections occurred in all groups, with some serious events reported, but no deaths, and most side effects were manageable. These findings support upadacitinib plus topical corticosteroids as an effective treatment option for both adults and adolescents with moderate-to-severe atopic dermatitis, with ongoing follow-up to assess longer-term safety and effectiveness.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and \< 18 years of age
- • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria.
- • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
- • Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
- • Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit
- Exclusion Criteria:
- • Prior exposure to any Janus kinase (JAK) inhibitor
- • Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
- • Requirement of prohibited medications during the study
- • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- • Female subject 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
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Irvine, California, United States
San Diego, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Centennial, Colorado, United States
Wheat Ridge, Colorado, United States
Shelton, Connecticut, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
North Miami Beach, Florida, United States
Orange Park, Florida, United States
Sunrise, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Wheaton, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Andover, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Chesterfield, Michigan, United States
Clarkston, Michigan, United States
Saint Joseph, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
East Windsor, New Jersey, United States
New York, New York, United States
Troy, New York, United States
Bexley, Ohio, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Warwick, Rhode Island, United States
Goodlettsville, Tennessee, United States
Murfreesboro, Tennessee, United States
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Kogarah, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
Woolloongabba, Queensland, Australia
Fremantle, Western Australia, Australia
Linz, Oberoesterreich, Austria
Linz, Oberoesterreich, Austria
Innsbruck, Tirol, Austria
Vienna, Wien, Austria
Jette, Bruxelles Capitale, Belgium
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Gent, Oost Vlaanderen, Belgium
Loverval, Belgium
Calgary, Alberta, Canada
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
St. John's, Newfoundland And Labrador, Canada
Halifax, Nova Scotia, Canada
Markham, Ontario, Canada
Mississauga, Ontario, Canada
Oakville, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint Jerome, Quebec, Canada
Beijing, Beijing, China
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Shenyang, Liaoning, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Beijing, China
Changsha, China
Shanghai, China
Plzen, Czechia
Prague, Czechia
Praha, Czechia
Praha, Czechia
Nice, Alpes Maritimes, France
Marseille Cedex 05, Bouches Du Rhone, France
Tours, Centre Val De Loire, France
Bordeaux, France
Reims, France
Heidelberg, Baden Wuerttemberg, Germany
Frankfurt Am Main, Hessen, Germany
Muenster, Nordrhein Westfalen, Germany
Selters, Rheinland Pfalz, Germany
Kiel, Schleswig Holstein, Germany
Bonn, Germany
Hamburg, Germany
Hannover, Germany
Mainz, Germany
Munich, Germany
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Stavroupoli (Thessalonikis), Thessaloniki, Greece
Thessaloniki, Greece
Hong Kong, Hong Kong
Hong Kong, Hong Kong
Oroshaza, Bekes, Hungary
Szeged, Csongrad, Hungary
Debrecen, Hajdu Bihar, Hungary
Debrecen, Hungary
Szolnok, Hungary
Dublin 8, Dublin, Ireland
Cork, Ireland
Waterford, Ireland
Be'er Sheva, Hadarom, Israel
Ramat Gan, Tel Aviv, Israel
Tel Aviv Yafo, Tel Aviv, Israel
Afula, Israel
Petakh Tikva, Israel
Rome, Lazio, Italy
Rozzano, Milano, Italy
Ancona, Italy
Catania, Italy
Milan, Italy
Napoli, Italy
Nagoya Shi, Aichi, Japan
Fukuoka Shi, Fukuoka, Japan
Hiroshima Shi, Hiroshima, Japan
Amagasaki Shi, Hyogo, Japan
Sagamihara Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Kyoto Shi, Kyoto, Japan
Sendai Shi, Miyagi, Japan
Habikino Shi, Osaka, Japan
Shimotsuke Shi, Tochigi, Japan
Bunkyo Ku, Tokyo, Japan
Hachioji Shi, Tokyo, Japan
Koto Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Rotterdam, Zuid Holland, Netherlands
Amsterdam, Netherlands
Groningen, Netherlands
Utrecht, Netherlands
Hamilton, New Zealand
Bergen, Hordaland, Norway
Harstad, Troms, Norway
Tromso, Troms, Norway
Oslo, Norway
Caguas, Puerto Rico
San Juan, Puerto Rico
San Juan, Puerto Rico
Banska Bystrica, Slovakia
Martin, Slovakia
Nove Zamky, Slovakia
Presov, Slovakia
Puerto Real, Cadiz, Spain
Alicante, Spain
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Lund, Skane Lan, Sweden
Gothenburg, Vastra Gotalands Lan, Sweden
Stockholm, Sweden
Stockholm, Sweden
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Oxford, Oxfordshire, United Kingdom
Dundee, Scotland, United Kingdom
Glasgow, Scotland, United Kingdom
Leeds, United Kingdom
Phoenix, Arizona, United States
Sapporo Shi, Hokkaido, Japan
Kyoto Shi, Kyoto, Japan
London, United Kingdom
London, United Kingdom
London, 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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