Actively Recruiting
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
Led by AbbVie · Updated on 2025-12-24
123
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults in Japan who have severe alopecia areata (AA), an autoimmune condition causing hair loss on the scalp and other parts of the body. This Phase 3, randomized, double-blind study includes participants with at least 25% scalp hair loss and ongoing AA episodes less than 8 years. The study is sponsored by AbbVie and aims to better understand treatment options for this condition. Participants are assigned to one of three groups in Period A: two different doses of upadacitinib or placebo, taken orally once daily for up to 24 weeks. In Period B, those on upadacitinib continue their dose for 52 weeks, while those initially on placebo are re-randomized to one of the two upadacitinib doses for 28 weeks. After Period B, participants may enter Period C for up to 52 weeks, where dosing is adjusted based on their Severity of Alopecia Tool (SALT) score. Participants with no improvement at or after Week 40 may receive open-label upadacitinib dose B. Throughout the study, participants will attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will evaluate outcomes such as the percentage of participants achieving a SALT score of 10 or less at Week 24, and record any adverse events up to approximately 108 weeks. There is a follow-up period of up to 30 days after the last dose to monitor safety.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is judged to be in good health based on screening assessments and medical history.
- Diagnosis of severe alopecia areata with a SALT score of 25 or higher (at least 25% scalp hair loss) at screening and baseline.
- Current episode of alopecia areata is less than 8 years in duration.
- Participants aged between 12 and 63 years.
You will not qualify if you...
- Current diagnosis of primarily diffuse type alopecia areata.
- Diagnosis of other types of alopecia that interfere with assessment, including female pattern hair loss, male pattern hair loss (Stage III or higher), traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium.
- Other inflammatory scalp, eyebrow, or eyelash disorders interfering with alopecia areata evaluation, such as seborrheic dermatitis, scalp psoriasis, atopic dermatitis, and tinea capitis.
- Active infections requiring intravenous anti-infective treatment within 30 days or oral/intramuscular treatment within 14 days before baseline.
- Chronic recurring or active viral infections that make the participant unsuitable for the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks in Period A and Period B; additional 52 weeks in Period C for some participants depending on response
Participants receive upadacitinib or placebo tablets once daily as part of the study treatment.
Regular visits throughout treatment periods
Trial Site Locations
Total: 15 locations
1
Nagoya City University Hospital /ID# 275409
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
2
Kurume University Hospital /ID# 275519
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
3
Kanazawa Medical University Hospital /ID# 275521
Kahoku-gun, Ishikawa-ken, Japan, 920-0265
Actively Recruiting
4
Nagomi Dermatology Clinic /ID# 275418
Ebina-shi, Kanagawa, Japan, 243-0432
Actively Recruiting
5
Rifu Dermatology Allergy Clinic /ID# 274875
Miyagi-gun, Miyagi, Japan, 981-0112
Actively Recruiting
6
Tohoku University Hospital /ID# 274931
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
7
Niigata University Medical & Dental Hospital /ID# 274775
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
8
Shinsaibashi Inui Dermatology Clinic /ID# 274851
Osaka, Osaka, Japan, 542-0081
Actively Recruiting
9
Osaka Metropolitan University Hospital /ID# 274956
Osaka, Osaka, Japan, 545-8586
Actively Recruiting
10
Hamamatsu University Hospital /ID# 274639
Hamamatsu, Shizuoka, Japan, 431-3192
Actively Recruiting
11
Kyorin University Hospital /ID# 274882
Mitaka-shi, Tokyo, Japan, 181-8611
Actively Recruiting
12
Tokyo Medical University Hospital /ID# 274844
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
13
Keio University Hospital /ID# 275640
Shinjuku-ku, Tokyo, Japan, 160-8582
Actively Recruiting
14
Yamaguchi University Hospital /ID# 274638
Ube, Yamaguchi, Japan, 755-8505
Actively Recruiting
15
Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424
Tokyo, Japan, 136-0075
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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