A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed.
Upadacitinib is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B), an optional exploratory NB-UVB phototherapy study (Study 3), and a re-randomized dose-escalation study (Study 4). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo. In Period B, all participants will receive upadacitinib. Approximately 540 adult and adolescent participants with NSV will be enrolled between each main study at around 180 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI90 at week 48 while on study drug, to enter Study 3. Participants who failed to achieve T-VASI75 response at week 118 of Study 1 or 2 or at week 70 of Study 3 will be considered for entry into Study 4.
In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with Narrow-Band Ultraviolet B (NB-UBV) phototherapy for at least 24 weeks followed by upadacitinib alone. In Study 4, participants will be re-randomized to receive oral tablets of upadacitinib 15 mg or 30 mg once a day for 56 weeks.
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.
Inclusion Criteria:
Documented clinical diagnosis of non-segmented vitiligo (NSV).
At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:
Exclusion Criteria:
Los Angeles, California 90036-5679, United States
Worcester, Massachusetts 01655, United States
San Antonio, Texas 78229, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1055, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1425, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1425, Argentina
Buenos Aires, 1061, Argentina
Sofiya, Sofia 1407, Bulgaria
Sofiya, Sofia 1463, Bulgaria
Sofiya, Sofia 1618, Bulgaria
Québec, Quebec G1V 4X7, Canada
Beijing, Beijing Municipality 100730, China
Guangzhou, Guangdong 510260, China
Hangzhou, Zhejiang 310020, China
Wenzhou, Zhejiang 325000, China
Bordeaux, Gironde 33000, France
Bonn, Hesse 53111, Germany
Rome, Roma 00144, Italy
Sakai-shi, Osaka 593-8324, Japan
Suita-shi, Osaka 565-0871, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Osielsko, Kuyavian-Pomeranian Voivodeship 86-031, Poland
Krakow, Lesser Poland Voivodeship 30-002, Poland
Bialystok, Podlaskie Voivodeship 15-351, Poland
Suwon, Gyeonggido 16247, South Korea