A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.
Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).
Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.
Randomization for the Main Study will be stratified by Baseline disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the Adolescent Sub-study will be stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).
At Week 16 of both the Main Study and the Adolescent Sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). For the Adolescent Sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).
Starting at Week 4, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary The Primary Analysis for the Main Study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the Main Study and the Adolescent Sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.
Inclusion Criteria:
Exclusion Criteria:
Aurora, Colorado 80045-2517, United States
Wheat Ridge, Colorado 80033-2896, United States
Coral Gables, Florida 33134, United States
Boise, Idaho 83713, United States
Chicago, Illinois 60611-2927, United States
Skokie, Illinois 60077, United States
East Windsor, New Jersey 08520, United States
Tulsa, Oklahoma 74136-7049, United States
Goodlettsville, Tennessee 37072-2301, United States
Salt Lake City, Utah 84117-4209, United States
Guangzhou, Guangdong 510120, China
Wuhan, Hubei 430022, China
Hangzhou, Zhejiang 310006, China
Hangzhou, Zhejiang 310009, China
Kiel, Schleswig-Holstein 24105, Germany
Stavroupoli (Thessalonikis), Thessaloniki 55536, Greece
Szeged, Csongrád megye 6725, Hungary
Rome, Lazio 00168, Italy
Amagasaki-shi, Hyōgo 661-0953, Japan
Sagamihara-shi, Kanagawa 252-0392, Japan
Habikino-shi, Osaka 583-8588, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Hachioji-shi, Tokyo 192-0032, Japan
Koto-ku, Tokyo 136-0074, Japan
Shinjuku-ku, Tokyo 1690075, Japan
Banská Bystrica, 975 17, Slovakia
London, London, City of SE1 9RT, United Kingdom
London, London, City of SE1 9RT, United Kingdom
Oxford, Oxfordshire OX3 9DU, United Kingdom