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New pill could help regrow hair in severe alopecia

NCT ID NCT07023302

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a daily pill called upadacitinib for people with severe alopecia areata, an immune system attack on hair follicles causing at least 25% scalp hair loss. About 123 teens and adults in Japan will take either the drug or a placebo for up to 104 weeks to see if it safely regrows hair. The goal is to reduce hair loss to 10% or less of the scalp.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

125 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 63 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alopecia areata

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alopecia areata

Contacts and locations

Locations

  • Hamamatsu University Hospital /ID# 274639

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424

    Tokyo, 136-0075, Japan

  • Kanazawa Medical University Hospital /ID# 275521

    Kahoku-gun, Ishikawa-ken, 920-0265, Japan

  • Keio University Hospital /ID# 275640

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Kurume University Hospital /ID# 275519

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Kyorin University Hospital /ID# 274882

    Mitaka-shi, Tokyo, 181-8611, Japan

  • Nagomi Dermatology Clinic /ID# 275418

    Ebina-shi, Kanagawa, 243-0432, Japan

  • Nagoya City University Hospital /ID# 275409

    Nagoya, Aichi-ken, 467-8602, Japan

  • Niigata University Medical and Dental Hospital /ID# 274775

    Niigata, Niigata, 951-8520, Japan

  • Osaka Metropolitan University Hospital /ID# 274956

    Osaka, Osaka, 545-8586, Japan

  • Rifu Dermatology Allergy Clinic /ID# 274875

    Miyagi-gun, Miyagi, 981-0112, Japan

  • Shinsaibashi Inui Dermatology Clinic. /ID# 274851

    Osaka, Osaka, 542-0081, Japan

  • Tohoku University Hospital /ID# 274931

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Medical University Hospital /ID# 274844

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Yamaguchi University Hospital /ID# 274638

    Ube, Yamaguchi, 755-8505, Japan

More trials for these conditions

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