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Hair loss drug shows promise in major trial

NCT ID NCT03570749

Disease control Sponsor: Eli Lilly and Company 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested baricitinib, an anti-inflammatory pill, in 784 adults with severe or very severe alopecia areata, a condition causing extensive hair loss. Participants received either baricitinib or a placebo for up to 52 weeks. The main goal was to see if baricitinib could regrow scalp hair to 80% or more of normal coverage. The trial also included an open-label part for some U.S. participants.

What this could mean

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

Active substance
Baricitinib (a pill that targets inflammation)
What this could lead to
If successful, this could provide a new treatment option for people with severe alopecia areata, helping them regrow significant scalp hair.
What could go wrong
This is a completed trial, but results may not apply to all patients. Baricitinib can have side effects like infections or blood clots, and not everyone may respond.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

784 people

The number who actually took part.

Started

Sep 2018

Finished

Jan 2025

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 70 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: * Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent. * Must self-identify as either Black or African American in race in the open label addenda. * Have severe or very severe AA, as determined by all of the following: * Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline. * No spontaneous improvement over the past 6 months. * Current episode of severe or very severe AA of less than 8 years. * Male or nonpregnant, nonbreastfeeding female participants. Exclusion Criteria: * Primarily "diffuse" type of AA. * Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA. * Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).

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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

  • ActivMed Practices and Research

    Beverly, Massachusetts, 01915, United States

  • ActivMed Practices and Research

    Portsmouth, New Hampshire, 03801, United States

  • Alliance Research Centers

    Irvine, California, 92612, United States

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660, United States

  • B&B Investigaciones Medicas, SC

    Mazatlán, Sinaloa, 82140, Mexico

  • Bellaire Dermatology

    Bellaire, Texas, 77401, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CRI Centro Regiomontano de Investigacion S.C.

    Monterrey, Nuevo León, 64060, Mexico

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024, United States

  • Callender Center for Clinical Research, LLC / Research

    Glenn Dale, Maryland, 20769, United States

  • Center for Clinical Studies

    Houston, Texas, 77004, United States

  • Center for Clinical Studies

    Webster, Texas, 77598, United States

  • Chonbuk National University Hospital

    Jeonju, Jeon Ra Buk-Do, Korea, 54907, South Korea

  • Chungang University Hospital

    Seoul, 06973, South Korea

  • Chungnam National University Hospital

    Daejeon, Korea, 35015, South Korea

  • Clarkston Skin Research

    Clarkston, Michigan, 48346, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco, 44650, Mexico

  • Coastal Clinical Research, Inc

    Mobile, Alabama, 36608, United States

  • Consultorio Privado de la Dra. Villanueva

    Guadalajara, Jalisco, 44657, Mexico

  • Derma Norte del Bajío, S.C.

    Aguascalientes, Mexico

  • Dermatology Associates

    Seattle, Washington, 98101, United States

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology and Skin Surgery Center

    Exton, Pennsylvania, 19341, United States

  • Eunpyeong St. Mary's Hospital

    Seoul, 03312, South Korea

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244, United States

  • Forefront Research

    Louisville, Kentucky, 40241, United States

  • GCM Medical Group, PSC- Hato Rey

    San Juan, PR, 00917, Puerto Rico

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, N.L., 64460, Mexico

  • Inha University Hospital

    Jung-gu, Incheon, 22332, South Korea

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C

    Durango, 34000, Mexico

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916, United States

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Kurume University Hospital

    Kurume, Fukuoka, 830 0011, Japan

  • Kyung Pook National University Hospital

    Daegu, Korea, 41944, South Korea

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medaphase Inc

    Newnan, Georgia, 30263, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Modern Research Associates

    Dallas, Texas, 75231, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490, United States

  • Mosaic Dermatology

    Santa Monica, California, 90403, United States

  • NW Dermatology & Research Center, LLC

    Portland, Oregon, 97210, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • OH State Univ College of Med

    Gahanna, Ohio, 43230, United States

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239, United States

  • Oregon Medical Research Center

    Portland, Oregon, 97223, United States

  • Osaka City University Hospital

    Osaka, 545-8586, Japan

  • Park Avenue Dermatology

    Orange Park, Florida, 32073, United States

  • Penn State Univ. Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Ponce School of Medicine CAIMED Center

    Ponce, PR, 00716, Puerto Rico

  • Pusan National University Hospital

    Busan, Korea, 49241, South Korea

  • RM Pharma Specialists S.A. de C.V.

    Distrito Federal, 3100, Mexico

  • Seoul National University Bundang Hospital

    Seongnam, Geonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217, United States

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32256, United States

  • Stanford Health Care

    Redwood City, California, 94063, United States

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • Tokyo Medical Univ. Hospital

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • University Clinical Trials, Inc.

    San Diego, California, 92123, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of CA, Irvine

    Irvine, California, 92617, United States

  • University of California Davis-Dermatology

    Sacramento, California, 95816, United States

  • University of Miami

    Miami, Florida, 33125, United States

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester School of Medicine

    Rochester, New York, 14642, United States

  • University of Utah MidValley Dematology

    Murray, Utah, 84107, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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