Areata AlopeciaPhase 3BRAVE-AA-PEDSNCT05723198
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
A Phase 3 study testing Baricitinib in people with Areata Alopecia and Alopecia, run by Eli Lilly and Company at 127 sites in 12 countries.
Trial summary
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Areata Alopecia, Alopecia, Hypotrichosis
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 595 participants
- Where
- 127 sitesin 12 countries
- Study dates
- 27 Feb 2023to Sep 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
- Have severe areata alopecia (AA) for at least 1 year
- Diagnosis for at least 1 year
- Current AA episode of at least 6 months' duration
- SALT score ≥50% at screening and baseline
- History of trial and failure with at least 1 available treatment (topical or other) for AA
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- History of psychological counseling related to AA
- Current episode of severe AA of less than 8 years.
- Note: Participants who have 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.
Who cannot join
- Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
- Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
- Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
- Have uncontrolled arterial hypertension
- Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
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- Have a positive test for hepatitis B virus (HBV) infection
- Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid [RNA]).
- Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Trial locations and contacts
127 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
127 sites in 12 countries
United States44 sites, 41 recruiting
- Recruiting
Bexley Dermatology Research
Bexley, Ohio, 43209
614-725-5010
Matthew Zirwas
- Recruiting
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
205-380-6148
James Krell
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
205-502-9960
Lauren Smith Cole
- Not yet recruiting
Skin Care Research, Inc
Boca Raton, Florida, 33486
561-948-3116 x3053
Ann Reed
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
843-792-3021
Lara Wine Lee
- Recruiting
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
7042479179 x212
Deborah Nixon
- Completed
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
312-695-3721
Amy Paller
- Not yet recruiting
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
202-476-3395
Kalyani Marathe
- Recruiting
Michigan Center for Research Company
Clarkston, Michigan, 48346
248-620-3376
Wendy McFalda
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
216-844-5197
Neil Korman
- Completed
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
- Not yet recruiting
Dermatology Treatment and Research Center
Dallas, Texas, 75230
469-754-1585
Ross Radusky
- Not yet recruiting
D&H Doral Research Center LLC
Doral, Florida, 33122
786-698-8508
Brent Schillinger
- Not yet recruiting
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
760-203-3839
Stacy Smith
- Completed
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
- Not yet recruiting
Dermatology Physicians of Connecticut
Fairfield, Connecticut, 06824
203-785-4632
Brittany Craiglow
- Recruiting
Pediatric Dermatology of North Texas
Grapevine, Texas, 76051
972-354-1520
Fred Ghali
- Not yet recruiting
Skin Care Research, Inc
Hollywood, Florida, 33021
954-674-3535
Eduardo Weiss
- Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
317-516-5030 ext 115
Kenneth Dawes
- Recruiting
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256
904-619-8157
Pearl Kwong
- Recruiting
Dermatology Research Associates
Los Angeles, California, 90045
310-337-7171
Howard Sofen
- Recruiting
Skin Care Physicians of Georgia
Macon, Georgia, 31217
478-742-2180 ext 255
David Cohen
- Recruiting
University of Wisconsin-Madison
Madison, Wisconsin, 53715
608-287-2450
Lisa Arkin
- Not yet recruiting
University of Miami Miller School of Medicine
Miami, Florida, 33125
Mariya Miteva
- Recruiting
Pediatric Skin Research, LLC
Miami, Florida, 33156
786-585-5774
Mercedes Gonzalez
- Recruiting
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
612-625-8625
Maria Hordinsky
- Recruiting
International Clinical Research - Tennessee (IC Research)
Murfreesboro, Tennessee, 37130
615-410-3460
Christina Feser
- Not yet recruiting
University of Utah MidValley Dematology
Murray, Utah, 84107
801-587-1948
Jamie Rhoads
- Recruiting
Virginia Clinical Research
Norfolk, Virginia, 23502
757-625-0151
David Pariser
- Recruiting
Advanced Skin Research Center
Omaha, Nebraska, 68144
402-697-6599
Joel Schlessinger
- Recruiting
Northwest Dermatology Institute
Portland, Oregon, 97210
503-223-1933
Nisha Desai
- Recruiting
DermAssociates PC.
Rockville, Maryland, 20850
301-355-3183
Benjamin Lockshin
- Recruiting
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
816-364-1515
MELODY STONE
- Recruiting
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
(210) 852-2779 Ext. 1004
John Browning
- Recruiting
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, 92123
858-966-1700 ext. 224295
Dawn Eichenfield
- Recruiting
The Permanente Medical Group, Inc.
San Francisco, California, 94118
707-651-1000
Paradi Mirmirani
- Recruiting
Southern California Dermatology, Inc.
Santa Ana, California, 92701
714-547-5151
Jennifer Soung
- Recruiting
Investigate MD
Scottsdale, Arizona, 85255
480-440-5985
Brenda LaTowsky
- Recruiting
Northshore University Healthsystem
Skokie, Illinois, 60077
847-663-8530
Joel Joyce
- Recruiting
The South Bend Clinic Center for Research
South Bend, Indiana, 46617
574-204-6192
Holly Hake Harris
- Recruiting
Complete Dermatology
Sugar Land, Texas, 77479
281-240-4313
Vandana Madkan
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
718-920-8352
Holly Kanavy
- Recruiting
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
918-392-4550
Iftikhar Hussain
Poland14 sites, 14 recruiting
- Recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
587192222
Aleksandra Okuniewska
- Recruiting
CareClinic
Katowice, 40 568
609527827
Dominika Wcislo-Dziadecka
- Recruiting
Centrum Medyczne Angelius Provita
Katowice, 40-611
607566402
Anita Lewartowska-Bialek
- Recruiting
Gabinet Dermatologiczny
Kielce, 25-155
790258928
Beata Krecisz
- Recruiting
Specjalistyczny Gabinet Dermatologiczny s.c.
Krakow, 30 002
+48 600244514
Pawel Brzewski
- Recruiting
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, 90-436
609279389
Aleksandra Lesiak
- Recruiting
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszów, 35 055
605076722
Adam Reich
- Recruiting
DERMEDIC Jacek Zdybski
Swietokrzyski, 27 400
+48 693 721 891
Piotr Parcheta
- Recruiting
Provita Poliklinika Sp. z o.o.
Warsaw, 02 647
668361281
Mariusz Sikora
- Recruiting
Royalderm Agnieszka Nawrocka
Warsaw, 02 962
601316460
Witold Owczarek
- Recruiting
Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507
48225081482
Irena Walecka - Herniczek
- Recruiting
Centrum Medyczne Evimed
Warsaw, 02-625
733240763/ 48510175635
Monika Slowinska
- Recruiting
Klinika Ambroziak Sp. Z.O.O.
Warsaw, 02-953
502616031
Justyna Skibinska
- Recruiting
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, 50-566
601534853
Jacek Szepietowski
South Korea14 sites, 14 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
51 240 7338
Moon-Bum Kim
- Recruiting
Dankook University Hospital
Cheonan-si, 31116
10 9575 5146
Byung Cheol Park
- Recruiting
Chungnam national university hospital
Daejeon, 35015
10 5456 7348
Young Lee
- Recruiting
Inha University Hospital
Incheon, 22332
32 890 3737
Gwang Seong Choi
- Recruiting
Jeonbuk National University Hospital
Jeonju, 54907
10 3311 8402
Jin Park
- Recruiting
Kyungpook National University Hospital
Junggu, 41944
10 9268 8342
Nam Gyoung Ha
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
1066147796
Chang Hun Huh
- Recruiting
Seoul National University Hospital
Seoul, 03080
10 5445 9889
OHSANG KWON
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
2 2030 2845
HOON KANG
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
2 2228 2080
Do Young Kim
- Recruiting
Konkuk University Medical Center
Seoul, 05030
10 6286 2138
Yang-Won Lee
- Recruiting
Kyunghee University Hospital at Gangdong
Seoul, 05278
10 8948 7721
Bark-Lynn Lew
- Recruiting
Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
Seoul, 06973
10 5310 2419
Beomjoon Kim
- Recruiting
Ajou University Hospital
Suwon, 16499
10 9933 0102
Jee Woong Choi
Argentina8 sites, 7 recruiting
- Recruiting
Psoriahue Medicina Interdisciplinaria
Buenos Aires, C1425DKG
+5491150461624
Gabriel Alejandro Magarinos
- Recruiting
Fundación Respirar
Buenos Aires, C1426ABP
+5403814200180
Maria Fernandez
- Recruiting
Derma Internacional SA
Buenos Aires
5491139842833
Maria Galimberti
- Recruiting
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, C1055AA0
+541152190541
Matias Turienzo
- Recruiting
Instituto de Neumonología Y Dermatología
Ciudad Autonoma Buenos Aires, C1425BEA
5491145404544
Paula Luna
- Not yet recruiting
Hospital Universitario Austral
Pilar, 1629
+541127690233
Carla Castro
- Completed
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, T4000AXL
- Recruiting
Hospital del Niño Jesus
San Miguel de Tucumán, 4000
+5493815863707
Maria Fiandrino
Germany8 sites, 8 recruiting
- Recruiting
Fachklinik Bad Bentheim
Bad Bentheim, 48455
5922745210
Athanasios Tsianakas
- Recruiting
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117
30450518122
Ulrike Blume-Peytavi
- Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
3514582007
Roland Aschoff
- Recruiting
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, 60590
004969630183115
Andreas Pinter
- Recruiting
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, 22149
Peter Hoeger
- Recruiting
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, 55128
+49 34196280027
Sven Quist
- Not yet recruiting
Klinikum Rechts der Isar der TU München
München, 80802
0049-4140-3231
Christina Schnopp
- Recruiting
University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
Münster, 48149
2518357296
Nina Magnolo
Japan8 sites, 8 recruiting
- Recruiting
Hamamatsu University Hospital
Hamamatsu, 431-3192
81120023812
Taisuke Ito
- Recruiting
Kurume University Hospital
Kurume, 830-0011
81120023812
Yohei Natsuaki
- Recruiting
Kyorin University Hospital
Mitaka, 181-8611
81120023812
Misaki Kinoshita
- Recruiting
Rifu Dermatology Allergy Clinic
Miyagi-gun, 981 0112
81120023812
Masato Mizuashi
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
81120023812
Ryota Hayashi
- Recruiting
Osaka City University Hospital
Osaka, 545-8586
81120023812
Hisayoshi Imanishi
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023
81120023812
Kazutoshi Harada
- Recruiting
Yamaguchi University Hospital
Ube, 755-8505
81120023812
Yutaka Shimomura
Canada6 sites, 6 recruiting
- Recruiting
Dermatology Research Institute
Calgary, T2J 7E1
4032633376
Vimal Prajapati
- Recruiting
Skin Health
Cobourg, K9A 0Z4
(289) 252-1856
Melinda Gooderham
- Recruiting
Lynderm Research Inc.
Markham, L3P 1X2
905-471-8011
Charles Lynde
- Recruiting
Dr. Chih-ho Hong Medical Inc.
Surrey, V3R 6A7
604-953-1333
Gurbir Dhadwal
- Recruiting
Research Toronto
Toronto, M4W 2N2
416-962-0123
Sameh Hanna
- Recruiting
Wiseman Dermatology Research Inc.
Winnipeg, R3M 3Z4
204-943-4922
Marni Wiseman
France6 sites, 6 recruiting
- Not yet recruiting
CHRU de Brest - Hôpital Morvan
Brest, 29609
298223333
Claire Abasq
- Recruiting
AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
Marseille, 13005
0491384930
Stephanie Mallet
- Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093
02 40 08 48 86 (84 886)
Sebastien Barbarot
- Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06202
492036667
Thierry Passeron
- Recruiting
Centre de Sante Sabouraud
Paris, 75010
+33761453540
Pascal Reygagne
- Recruiting
Hôpital Clocheville Chru-Tours Département Dermatologie
Tours, 37044
33247474625
Annabel Maruani
Spain6 sites, 4 recruiting
- Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
934978754
Adria Plana Pla
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
+34 93 2483211
Alvaro March Rodriguez
- Completed
Hospital Universitario Basurto
Bilbao (Bizkaia), 48013
- Completed
Clinica Pedro Jaen
Madrid, 28006
- Recruiting
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid, 28031
626273207
Jose Luis Galan
- Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
+34 96 3131800
Altea Esteve Martinez
Taiwan6 sites, 6 recruiting
- Not yet recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
222490088
Woan-Ruoh Lee
- Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
910381121
Po-Ju Lai
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 70403
+886 62353535
Chao-Chun Yang
- Recruiting
National Taiwan University Hospital
Taipei, 100
+886 223562141
Tsen-Fang Tsai
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 11217
228757808
Chih-Chiang Chen
- Not yet recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
88627135211
Wen-Hung Chung
Australia4 sites, 3 recruiting
- Completed
Skin and Cancer Foundation Australia - Darlinghurst Clinic
Darlinghurst, 2010
- Recruiting
Sinclair Dermatology
Melbourne, 3002
3 9013 0099
Samantha Eisman
- Recruiting
Institute for Skin, Health, and Immunity
Mitcham, 3132
412476267
John Su
- Recruiting
Veracity Clinical Research Pty Ltd
Wooloongabba, 4102
730391346
Lynda Spelman
Hungary3 sites, 2 recruiting
- Completed
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, 4032
- Not yet recruiting
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
+36 30 3005085
Beata Fabos
- Recruiting
Pecsi Tudomanyegyetem
Pécs, 7632
+36 72 536 633
Adriana Csernus
About this study
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.
The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.
- Conditions
- Areata Alopecia, Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical
- Being tested
- Baricitinib, Placebo
- Medical subject headings
- Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib High Dose | Experimental | Participants will receive baricitinib high dose orally. Receives: Drug: Baricitinib |
| Baricitinib Low Dose | Experimental | Participants will receive baricitinib low dose orally. Receives: Drug: Baricitinib |
| Placebo | Placebo comparator | Participants will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Measured: Week 36
Secondary outcomes (20)
Percent Change from Baseline in SALT Score
Measured: Baseline, Week 36
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Measured: Week 36
Percentage of Participants Achieving an Absolute SALT ≤10
Measured: Week 36
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline
Measured: Week 36
Mean Change from Baseline in SALT Score
Measured: Baseline, Week 36
Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
Measured: Week 36
Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
Measured: Week 36
Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
Measured: Week 36
Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss ≥2 at Baseline
Measured: Week 36
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss ≥2 at Baseline
Measured: Week 36
Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB ≥2 at Baseline)
Measured: Week 36
Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL ≥2 at Baseline)
Measured: Week 36
Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
The HADS is a participant-rated instrument used to assess both anxiety and depression and is available in a pediatric self-report for participants ≥12 years old. This instrument consists of 14 item questionnaires, each item is rated on a 4-point scale. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
Measured: Week 36
Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages ≥5 years). Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days". Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater anxiety.
Measured: Baseline, Week 36
Mean Change from Baseline in PROMIS Depression Score
The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages ≥5 years). Both pediatric self-report and proxy-report versions assess depression "in the past seven days." Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater depression.
Measured: Baseline, Week 36
Mean Change from Baseline in PROMIS Peer Relationship Score
The PROMIS Peer Relationships Short Form planned to be used in the study measures 2 aspects of social functioning, friendship quality and peer acceptance, and is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to <8 years).
Measured: Baseline, Week 36
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
The FDLQI is a 10-item validated questionnaire designed for adult (>16 years old) family members of participants. The questionnaire is completed by family members of the AA participants (for example, parents/caregivers) and measures the secondary impact of the participant's skin disease on family QoL. Response categories include "not at all/not relevant," "only a little," "quite a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, with unanswered ("not relevant") responses scored as 0.
Measured: Baseline, Week 36
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Measured: Baseline through Week 36
PK: Area Under the Concentration Curve (AUC)
Measured: Baseline through Week 36
Change of Immunoglobulin G (IgG) Titers
Measured: Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start27 Feb 2023
- Primary completionMar 2028 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Areata AlopeciaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 595 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723198
- Sponsor's protocol ID
- 16875
- Other IDs
- I4V-MC-JAIO, 2022-502700-78-00
- Acronym
- BRAVE-AA-PEDS
- Status last verified
- Nov 2026
- First submitted
- 3 Feb 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
- ClinicalTrials.gov ID
- NCT05723198
- Acronym / sponsor ID
- BRAVE-AA-PEDS / 16875
- Conditions
- Areata Alopecia, Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 595 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.
The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baricitinib High Dose | Experimental | Drug: BaricitinibParticipants will receive baricitinib high dose orally. |
| Baricitinib Low Dose | Experimental | Drug: BaricitinibParticipants will receive baricitinib low dose orally. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
- Have severe areata alopecia (AA) for at least 1 year
- Diagnosis for at least 1 year
- Current AA episode of at least 6 months' duration
- SALT score ≥50% at screening and baseline
Key exclusion criteria (9 listed)
- Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
- Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
- Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
- Have uncontrolled arterial hypertension
- Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: LY3009104Administered orally | Drug | Baricitinib High Dose, Baricitinib Low Dose |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Time frame: Week 36
20 secondary outcomes
Percent Change from Baseline in SALT Score
Time frame: Baseline, Week 36
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Time frame: Week 36
Percentage of Participants Achieving an Absolute SALT ≤10
Time frame: Week 36
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline
Time frame: Week 36
Mean Change from Baseline in SALT Score
Time frame: Baseline, Week 36
Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
Time frame: Week 36
Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
Time frame: Week 36
Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
Time frame: Week 36
Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss ≥2 at Baseline
Time frame: Week 36
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss ≥2 at Baseline
Time frame: Week 36
Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB ≥2 at Baseline)
Time frame: Week 36
Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL ≥2 at Baseline)
Time frame: Week 36
Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
Time frame: Week 36
Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
Time frame: Baseline, Week 36
Mean Change from Baseline in PROMIS Depression Score
Time frame: Baseline, Week 36
Mean Change from Baseline in PROMIS Peer Relationship Score
Time frame: Baseline, Week 36
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
Time frame: Baseline, Week 36
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Time frame: Baseline through Week 36
PK: Area Under the Concentration Curve (AUC)
Time frame: Baseline through Week 36
Change of Immunoglobulin G (IgG) Titers
Time frame: Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia AreataLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Related trials for Areata Alopecia
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
127 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib in people with Areata Alopecia and Alopecia, run by Eli Lilly and Company at 127 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 127 sites in United States, Poland, South Korea, Argentina, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20 (time frame: Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.