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New pill shows promise for regrowing hair in severe alopecia

NCT ID NCT03899259

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug baricitinib in 606 adults with severe or very severe alopecia areata, a condition causing significant hair loss. Participants took either baricitinib or a placebo pill daily for up to 36 weeks. The main goal was to see if baricitinib could regrow enough scalp hair to reach a SALT score of 20 or less (meaning 80% or more hair coverage). Results showed that baricitinib helped many people regrow hair compared to placebo.

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 offer a new treatment option for people with severe alopecia areata, helping regrow scalp hair.
What could go wrong
This is a completed Phase 3 trial, but baricitinib may not work for everyone and has potential side effects like infections or blood clots. Long-term safety data are still limited.

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

606 people

The number who actually took part.

Started

Jul 2019

Finished

Nov 2024

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. * 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 SALT (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. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 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

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000, China

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Associated Skin Care Specialists

    New Brighton, Minnesota, 55112, United States

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020, China

  • Beijing Friendship Hospital Affiliate of Capital University

    Beijing, Beijing Municipality, 100050, China

  • Bexley Dermatology Research

    Bexley, Ohio, 43209, United States

  • Boramae Medical Center

    Dongjak-gu, Seoul-teukbyeolsi [Seoul], 07061, South Korea

  • Buenos Aires Skin

    Buenos Aires, Buenos Aires F.D., 1055, Argentina

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California, 94538, United States

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1027, Argentina

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13034-685, Brazil

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Chung Shan Medical University Hospital

    Taichung, Taichung, 402, Taiwan

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047, United States

  • Clinical Research Puerto Rico

    San Juan, 00909, Puerto Rico

  • Clinical Trials SA Pty Ltd

    Campbelltown, South Australia, 5073, Australia

  • Dankook University Hospital

    Cheonan, Chungcheongnam-do, 31116, South Korea

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dermatologists of Southwest Ohio

    Mason, Ohio, 45040, United States

  • Dermatology Specialists of Charlotte

    Charlotte, North Carolina, 28211, United States

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland, 20850, United States

  • Emek Medical Center

    Afula, Northern District, 1834111, Israel

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-870, Brazil

  • First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 30001, China

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida, 33134, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244, United States

  • Fremantle Dermatology

    Fremantle, Western Australia, 6160, Australia

  • Fundacion Respirar

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1426ABO, Argentina

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706, United States

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong, 510018, China

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001, Israel

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059, United States

  • Hospital de Clínicas Da Universidade Estadual de Campinas

    Campinas, São Paulo, 13083-888, Brazil

  • HuaShan Hospital Affiliated To Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 22241-180, Brazil

  • IDERJ - Instituto de Dermatologia e Estética do Brasil

    Rio de Janeiro, Rio de Janeiro, 22470-220, Brazil

  • IPITEC

    São Paulo, 01223-001, Brazil

  • Instituto de Neumonología y Dermatología

    Capital Federal, Buenos Aires, 1425, Argentina

  • Investigate MD

    Scottsdale, Arizona, 85255, United States

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Joseph J. Schwartz, M.D.

    Troy, New York, 12180, United States

  • Juntendo Tokyo Koto Geriatric Medical Center

    Koto-ku, Tokyo, 136-0075, Japan

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kaiser Permanente Hospital

    San Francisco, California, 94118, United States

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611, Japan

  • Kyunghee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi [Seoul], 134-090, South Korea

  • M3-Emerging Medical Research

    Raleigh, North Carolina, 27612, United States

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • New England Research Associates

    Bridgeport, Connecticut, 06606, United States

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Northwest Dermatology Institute

    Portland, Oregon, 97210, United States

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210, United States

  • Osaka City University Hospital

    Osaka, 545-8586, Japan

  • Parra Dermatología

    Mendoza, 5500, Argentina

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • Qualmedica Research, LLC

    Owensboro, Kentucky, 42303, United States

  • Quest Dermatology Research

    Northridge, California, 91324, United States

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Medical Center

    Haifa, Northern District, 3109601, Israel

  • Servidor Público Estadual - IAMSPE - centro de estudos urológicos

    São Paulo, 04039-901, Brazil

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200071, China

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • Sinclair Dermatology

    Melbourne, Victoria, 3002, Australia

  • Skin & Cancer Foundation Australia

    Westmead, New South Wales, 2045, Australia

  • Skin Health Institute Inc.

    Carlton, Victoria, 3053, Australia

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Soroka Medical Center

    Beersheba, Southern District, 8410101, Israel

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906, Israel

  • Stat Research

    CABA, Buenos Aires, C1023AAB, Argentina

  • Suzanne Bruce and Associates, PA

    Houston, Texas, 77056, United States

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

  • The South Bend Clinic Center for Research

    South Bend, Indiana, 46617, United States

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27516, United States

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Tokyo Medical Univ. Hospital

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama, 35205, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818, United States

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102, Australia

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502, United States

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136, United States

  • Woden Dermatology

    Phillip, Australian Capital Territory, 2606, Australia

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505, Japan

  • Yokohama Rosai Hospital

    Yokohama, Kanagawa, 222-0036, Japan

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014, China

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