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New drug shows promise for regrowing hair in severe alopecia

NCT ID NCT06018428

Disease control Sponsor: Q32 Bio Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called bempikibart (ADX-914) in 75 adults with severe alopecia areata, a condition causing significant scalp hair loss. In the first part, some participants received the drug and some a placebo to see if it helps hair regrow. The second part gives the drug to all participants to check safety and effectiveness over a longer period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bempikibart (ADX-914)
What this could lead to
If successful, this could offer a new treatment option for people with severe alopecia areata, potentially regrowing significant scalp hair.
What could go wrong
This is an early Phase 2 trial with only 75 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2026

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

18 to 75 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.

Key Inclusion Criteria: 1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent. 2. Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score. Key Exclusion Criteria: 1. History of or diagnosis at screening of any another form of alopecia based on assessment by investigator. 2. History (lifetime) or presence of hair transplants. 3. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted). 4. Use of systemic, topical, or device-based therapy for AA. 5. History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.

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Conditions

The condition(s) this trial relates to.

alopecia alopecia areata dermatitis

As listed by the trial registrant

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

Alopecia areata

Contacts and locations

Locations

  • Austin, Texas

    Austin, Texas, 78759, United States

  • Bexley, Ohio

    Bexley, Ohio, 43209, United States

  • Bowling Green, Kentucky

    Bowling Green, Kentucky, 42104, United States

  • Burlington, Massachusetts

    Burlington, Massachusetts, 01805, United States

  • Clarksville, Indiana

    Clarksville, Indiana, 47129, United States

  • Clinical Trials

    Canton, Ohio, 44718, United States

  • Clinical Trials

    Calgary, Alberta, T1Y 0B4, Canada

  • Clinical Trials

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Clinical Trials

    Oakville, Ontario, L6J 7W5, Canada

  • Clinical Trials

    Peterborough, Ontario, K9J 5K2, Canada

  • Clinical Trials

    Waterloo, Ontario, N2J 1C4, Canada

  • Encinitas, California

    Encinitas, California, 92024, United States

  • Fayetteville, Arkansas

    Fayetteville, Arkansas, 72703, United States

  • Fountain Valley, California

    Fountain Valley, California, 92708, United States

  • Frisco, Texas

    Frisco, Texas, 75034, United States

  • Hot Springs, Arkansas

    Hot Springs, Arkansas, 71913, United States

  • Houston, Texas

    Houston, Texas, 77056, United States

  • Jordan, Utah

    Jordan, Utah, 84095, United States

  • Lomita, California

    Lomita, California, 90717, United States

  • Mason, Ohio

    Mason, Ohio, 45040, United States

  • Mayfield Heights, Ohio

    Mayfield Heights, Ohio, 44124, United States

  • Miami, Florida

    Miami, Florida, 33173, United States

  • New Haven, Connecticut

    New Haven, Connecticut, 06519, United States

  • New York, New York

    New York, New York, 10012, United States

  • New York, New York

    New York, New York, 10023, United States

  • Portland, Oregon

    Portland, Oregon, 97225, United States

  • San Antonio, Texas

    San Antonio, Texas, 78213, United States

  • Scottsdale, Arizona

    Scottsdale, Arizona, 85255, United States

  • Spokane, Washington

    Spokane, Washington, 99202, United States

  • Tampa, Florida

    Tampa, Florida, 33613, United States

  • Troy, Michigan

    Troy, Michigan, 48084, United States

  • Warren, Michigan

    Warren, Michigan, 48192, United States

  • Wilmington, North Carolina

    Wilmington, North Carolina, 28405, United States

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