Upadacitinib tablets for adults and adolescents in Japan with severe alopecia areata

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

This study tests whether upadacitinib tablets can safely help adolescents and adults in Japan with severe alopecia areata regrow hair compared with placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 123 (estimated)
• Ages: 12 Years to 63 Years
• Sex: All
• Sponsor: AbbVie (industry)
• Drugs / interventions: upadacitinib
• Locations: 15 sites (Nagoya, Aichi-ken and 14 other locations)
• Trial ID: NCT07023302 on ClinicalTrials.gov

What this trial studies

This randomized Phase 3 trial enrolls adolescents and adults in Japan with severe alopecia areata (SALT ≥25) and a current episode under eight years. In the initial treatment period participants are randomized into one of three arms, with about one-third receiving placebo and the others receiving different doses of upadacitinib. Participants on upadacitinib continue their assigned dose into the next period, while those on placebo are re-randomized to active treatment; completers may join an extension receiving upadacitinib for up to 52 weeks. Safety, tolerability, and hair regrowth outcomes are monitored throughout the study with regular clinic visits and standardized assessments.

Who should consider this trial

Good fit: Adolescents and adults in Japan with severe alopecia areata (SALT score ≥25), a current episode under eight years, and otherwise judged in good health are the intended participants.

Not a fit: People with primarily diffuse hair loss, scarring alopecia, advanced pattern hair loss, or other inflammatory scalp disorders that interfere with AA evaluation are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, upadacitinib could help people with severe alopecia areata regrow significant scalp hair and improve quality of life.

How similar studies have performed: Other JAK inhibitors have shown effectiveness for alopecia areata, and earlier-phase studies of upadacitinib have suggested benefit, which this Phase 3 program aims to confirm.

Eligibility criteria

Inclusion Criteria:

* Participant is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history.
* 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 primarily diffuse type of AA.
* 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.

Where this trial is running

Nagoya, Aichi-ken and 14 other locations

• Nagoya City University Hospital /ID# 275409 — Nagoya, Aichi-ken, Japan (RECRUITING)
• Kurume University Hospital /ID# 275519 — Kurume-shi, Fukuoka, Japan (RECRUITING)
• Kanazawa Medical University Hospital /ID# 275521 — Kahoku-gun, Ishikawa-ken, Japan (RECRUITING)
• Nagomi Dermatology Clinic /ID# 275418 — Ebina-shi, Kanagawa, Japan (RECRUITING)
• Rifu Dermatology Allergy Clinic /ID# 274875 — Miyagi-gun, Miyagi, Japan (RECRUITING)
• Tohoku University Hospital /ID# 274931 — Sendai, Miyagi, Japan (RECRUITING)
• Niigata University Medical & Dental Hospital /ID# 274775 — Niigata, Niigata, Japan (RECRUITING)
• Shinsaibashi Inui Dermatology Clinic /ID# 274851 — Osaka, Osaka, Japan (RECRUITING)
• Osaka Metropolitan University Hospital /ID# 274956 — Osaka, Osaka, Japan (RECRUITING)
• Hamamatsu University Hospital /ID# 274639 — Hamamatsu, Shizuoka, Japan (RECRUITING)
• Kyorin University Hospital /ID# 274882 — Mitaka-shi, Tokyo, Japan (RECRUITING)
• Tokyo Medical University Hospital /ID# 274844 — Shinjuku-ku, Tokyo, Japan (RECRUITING)
• Keio University Hospital /ID# 275640 — Shinjuku-ku, Tokyo, Japan (RECRUITING)
• Yamaguchi University Hospital /ID# 274638 — Ube, Yamaguchi, Japan (RECRUITING)
• Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424 — Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Alopecia Areata, Upadacitinib, JUMP-UP, AA