A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata
NCT ID: NCT07023302
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
123 participants
INTERVENTIONAL
2025-06-19
2029-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1A: Upadacitinib Dose A
Participants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B.
Upadacitinib
Oral Tablets
Group 2A: Upadacitinib Dose B
Participants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B.
Upadacitinib
Oral Tablets
Group 3A: Upadacitinib Placebo
Participants will receive upadacitinib placebo once daily for 24 weeks in Period A.
Upadacitinib Placebo
Oral Tablets
Group 1B: Upadacitinib Dose A
Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose A once daily for 28 weeks in Period B.
Upadacitinib
Oral Tablets
Group 2B: Upadacitinib Dose B
Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose B once daily for 28 weeks in Period B.
Upadacitinib
Oral Tablets
Period C: Upadacitinib Dose A Remains Dose A
For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a Severity of Alopecia Tool (SALT) score \<= 10 at Week 52 (end of Period B) will remain on blinded upadacitinib dose A once daily in Period C for 52 weeks.
Upadacitinib
Oral Tablets
Period C: Upadacitinib Dose A to Dose B
For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a SALT score \> 10 at Week 52 (end of Period B) will dose escalate to blinded upadacitinib dose B once daily in Period C for 52 weeks.
Upadacitinib
Oral Tablets
Period C: Upadacitinib Dose B Non-Sustained Responders
For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score \> 10 at Week 40 or Week 52 will remain on blinded upadacitinib dose B once daily in Period C for 52 weeks.
Upadacitinib
Oral Tablets
Period C: Upadacitinib Dose B Sustained Responders
For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score \<= 10 at Week 40 and Week 52 will receive blinded upadacitinib dose A once daily in Period C for 52 weeks.
Upadacitinib
Oral Tablets
Period C: Open-Label Upadacitinib Dose B
Participants with no improvement or worsening from Baseline in their SALT score at the Week 40 visit or any scheduled visit thereafter will receive open-label upadacitinib dose B once daily for 52 weeks.
Upadacitinib
Oral Tablets
Interventions
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Upadacitinib
Oral Tablets
Upadacitinib Placebo
Oral Tablets
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \>= 25 (\>= 25% scalp hair loss) at Screening and Baseline.
* Current episode of AA of less than 8 years.
Exclusion Criteria
* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.
* Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit.
* Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study.
12 Years
63 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Kyorin University Hospital /ID# 274882
Mitaka-shi, Tokyo, Japan
Tokyo Medical University Hospital /ID# 274844
Shinjuku-ku, Tokyo, Japan
Keio University Hospital /ID# 275640
Shinjuku-ku, Tokyo, Japan
Yamaguchi University Hospital /ID# 274638
Ube, Yamaguchi, Japan
Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424
Tokyo, , Japan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M24-600
Identifier Type: -
Identifier Source: org_study_id