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New drug aimed at regrowing hair in severe alopecia

NCT ID NCT06444451

Disease control Sponsor: Sanofi 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 3 times

Summary

This study tested a drug called amlitelimab in 166 adults with severe alopecia areata, a condition causing significant hair loss. Participants received either the drug or a placebo by injection. The main goal was to see if the drug could reduce hair loss scores after 36 weeks. The trial was terminated early, so results are limited.

What this could mean

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

Active substance
amlitelimab
What this could lead to
If it works, this could point toward a new treatment option for people with severe alopecia areata, potentially helping regrow hair.
What could go wrong
This is an early proof-of-concept study that was terminated, so results may be incomplete. The treatment may not work better than placebo, and side effects are possible.

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

166 people

The number who actually took part.

Started

Jun 2024

Finished

May 2026

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 years and older

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: * Definitive diagnosis of AA of more than 6 months. * Diagnosis of severe AA, as determined by all of the following: 1. Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits. 2. Current episode of severe hair loss of less than 8 years. Participants with a history of AA of more than 8 years who have observed episodes of terminal hair regrowth over their scalp ("moving patches" spontaneously or following treatment) in the past 8 years can be included. 3. Stable disease: no evidence of terminal hair regrowth within 6 months (less than 10% improvement over the past 6 months). (guidance: if participant reports to have quite a bit more hair than 6 months prior, then patient cannot be included). * Willingness in maintaining a consistent hair style and hair care, including hair products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the end of study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia. * Participants currently with any local or systemic active medical conditions, which in the opinion of the Investigator would interfere with evaluations of the IMP effect on AA due to scalp inflammation, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp. * Received the specified treatment regimens within the timeframe outlined in the protocol. * Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected. * Participants with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

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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

  • Apex Clinical Research Center- Site Number : 8400027

    Mayfield Heights, Ohio, 44124, United States

  • Center for Dermatology Clinical Research- Site Number : 8400008

    Fremont, California, 94538, United States

  • Cleveland Clinic- Site Number : 8400028

    Cleveland, Ohio, 44195, United States

  • DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013

    Charlotte, North Carolina, 28210, United States

  • Dawes Fretzin Clinical Research- Site Number : 8400010

    Indianapolis, Indiana, 46256, United States

  • Dermatology Research Associates - Los Angeles- Site Number : 8400015

    Los Angeles, California, 90045, United States

  • First OC Dermatology- Site Number : 8400014

    Fountain Valley, California, 92708, United States

  • Health Concepts- Site Number : 8400001

    Rapid City, South Dakota, 57702, United States

  • Icahn School of Medicine at Mount Sinai- Site Number : 8400003

    New York, New York, 10029, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1055, Argentina

  • Investigational Site Number : 0360001

    Sydney, New South Wales, 2010, Australia

  • Investigational Site Number : 0360003

    Melbourne, Victoria, 3002, Australia

  • Investigational Site Number : 1000001

    Sofia, 1612, Bulgaria

  • Investigational Site Number : 1240001

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Investigational Site Number : 1240003

    Hamilton, Ontario, L8L 3C3, Canada

  • Investigational Site Number : 1240005

    Calgary, Alberta, T2J 7E1, Canada

  • Investigational Site Number : 1240006

    Markham, Ontario, L3P 1X2, Canada

  • Investigational Site Number : 1240007

    Calgary, Alberta, T2W 4X9, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 1560001

    Shanghai, 200040, China

  • Investigational Site Number : 1560006

    Hangzhou, 310009, China

  • Investigational Site Number : 1560022

    Chengdu, 610041, China

  • Investigational Site Number : 2030011

    Prague, 150 00, Czechia

  • Investigational Site Number : 2030012

    Prague, 158 00, Czechia

  • Investigational Site Number : 2032104

    Ostrava, 702 00, Czechia

  • Investigational Site Number : 2500001

    Brest, 29200, France

  • Investigational Site Number : 2500002

    Nice, 06202, France

  • Investigational Site Number : 2500003

    Paris, 75010, France

  • Investigational Site Number : 2500004

    Rouen, 76031, France

  • Investigational Site Number : 2760001

    Hamburg, 20095, Germany

  • Investigational Site Number : 2760003

    Münster, 48149, Germany

  • Investigational Site Number : 2760004

    Osnabrück, 49074, Germany

  • Investigational Site Number : 2760006

    Augsburg, 86150, Germany

  • Investigational Site Number : 2760007

    Berlin, 10629, Germany

  • Investigational Site Number : 2760008

    Berlin, 10117, Germany

  • Investigational Site Number : 3800001

    Bologna, 40138, Italy

  • Investigational Site Number : 3800002

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3800003

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3800004

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3920001

    Yokohama, Kanagawa, 221-0825, Japan

  • Investigational Site Number : 3920001

    Yokohama, 221-0825, Japan

  • Investigational Site Number : 3920002

    Kamiamakusa, Kumamoto, 861-3106, Japan

  • Investigational Site Number : 3920003

    Ebina-shi, Kanagawa, 243-0432, Japan

  • Investigational Site Number : 3920004

    Fukuoka, 814-0171, Japan

  • Investigational Site Number : 3920005

    Koto-ku, Tokyo, 136-0075, Japan

  • Investigational Site Number : 3920006

    Tokyo, 160-0023, Japan

  • Investigational Site Number : 5280004

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 6420001

    Cluj-Napoca, 400006, Romania

  • Investigational Site Number : 7240002

    Córdoba, 14004, Spain

  • Investigational Site Number : 7240004

    Alicante, 03010, Spain

  • Investigational Site Number : 7240005

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240006

    Madrid, 28031, Spain

  • Investigational Site Number : 7240007

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Investigational Site Number : 7240008

    Madrid, 28040, Spain

  • Investigational Site Number : 7240010

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number : 8260001

    London, SE5 9RL, United Kingdom

  • Investigational Site Number : 8260003

    London, London, City of, SW10 9NH, United Kingdom

  • Investigational Site Number : 8260004

    Salford, Manchester, M6 8HD, United Kingdom

  • Investigational Site Number : 8260005

    Dundee, DD1 9SY, United Kingdom

  • Investigational Site Number : 8260006

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Investigational Site Number : 8260007

    London, SE1 9RT, United Kingdom

  • Joel Schlessinger, PC- Site Number : 8400021

    Omaha, Nebraska, 68144, United States

  • Michigan Center for Research Company- Site Number : 8400016

    Clarkston, Michigan, 48346, United States

  • New Horizon Research Center- Site Number : 8400017

    Miami, Florida, 33165, United States

  • Oregon Medical Research Center- Site Number : 8400002

    Portland, Oregon, 97201, United States

  • Progressive Clinical Research - San Antonio- Site Number : 8400019

    San Antonio, Texas, 78229, United States

  • Total Skin and Beauty Dermatology Center- Site Number : 8400018

    Birmingham, Alabama, 35205, United States

  • UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007

    Irvine, California, 92697, United States

  • Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004

    Tulsa, Oklahoma, 74136, United States

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Other studies related to the condition(s) this trial covers.