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A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Alopecia Areata and at Least 25% Scalp Hair Loss
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants in Japan with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In Period B, participants originally randomized to a upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will be re-randomized in 1 of 2 groups receiving upadacitinib. Participants who complete Period B can join Period C and will receive 1 of 2 doses of upadacitinib for up to 52 weeks based on their SALT score. Around 123 adolescent and adult participants with severe AA will be enrolled in the study at approximately 20 sites in Japan. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 104 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after their last study drug dose. 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.
Age
12 - 63 years
Sex
ALL
Healthy Volunteers
No
Nagoya City University Hospital /ID# 275409
Nagoya, Aichi-ken, Japan
Kurume University Hospital /ID# 275519
Kurume-shi, Fukuoka, Japan
Kanazawa Medical University Hospital /ID# 275521
Kahoku-gun, Ishikawa-ken, Japan
Nagomi Dermatology Clinic /ID# 275418
Ebina-shi, Kanagawa, Japan
Rifu Dermatology Allergy Clinic /ID# 274875
Miyagi-gun, Miyagi, Japan
Tohoku University Hospital /ID# 274931
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital /ID# 274775
Niigata, Niigata, Japan
Shinsaibashi Inui Dermatology Clinic /ID# 274851
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 274956
Osaka, Osaka, Japan
Hamamatsu University Hospital /ID# 274639
Hamamatsu, Shizuoka, Japan
Start Date
June 19, 2025
Primary Completion Date
February 1, 2029
Completion Date
February 1, 2029
Last Updated
December 24, 2025
123
ESTIMATED participants
Upadacitinib
DRUG
Upadacitinib Placebo
DRUG
Lead Sponsor
AbbVie
NCT06826196
NCT06562270
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07133308