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New drug hopes to regrow hair in severe alopecia

NCT ID NCT07205159

Disease control Sponsor: Forte Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a drug called FB102 in 32 adults with severe to very severe alopecia areata, a condition causing significant hair loss. Half receive the drug and half a placebo, all by IV. The main goal is to check safety, but researchers will also measure hair regrowth at 16 weeks using a standard scalp hair loss score.

What this could mean

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

Active substance
FB102 (given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for people with severe hair loss from alopecia areata.
What could go wrong
This is a very early Phase 1 trial with only 32 people, so it is primarily checking safety. It may not show clear hair regrowth, and side effects are unknown.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

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

Started

Oct 2025

Expected to finish

Mar 2027

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.

Inclusion Criteria: * Males aged 18-60 years and females aged 18-75 years at Screening. * Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss. * AT = complete scalp hair loss; AU = complete scalp, facial, and body hair loss. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria Exclusion Criteria: * Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia). * Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis). * Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis). Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Auckland

    NOT_YET_RECRUITING

    Auckland, Auckland, 0632, New Zealand

  • Christchurch

    NOT_YET_RECRUITING

    Christchurch, Canterbury, 8013, New Zealand

  • Coorparoo

    RECRUITING

    Coorparoo, Queensland, 4151, Australia

  • Palmerston North

    NOT_YET_RECRUITING

    Palmerston North, Palmerston North Central, 4414, New Zealand

  • South Yarra

    NOT_YET_RECRUITING

    South Yarra, Victoria, 3141, Australia

  • St Leonards

    NOT_YET_RECRUITING

    Saint Leonards, New South Wales (nsw), 2065, Australia

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