Actively Recruiting

Phase 3
Age: 6Years - 17Years
All Genders
NCT05723198

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Led by Eli Lilly and Company · Updated on 2026-04-17

595

Participants Needed

127

Research Sites

361 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 Period, and a 4-week Post-treatment Follow-up period.

CONDITIONS

Official Title

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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% or greater at screening and baseline
  • History of trial and failure with at least 1 available treatment (topical or other) for AA
  • History of psychological counseling related to AA
  • Current episode of severe AA of less than 8 years
  • Participants with severe AA for 8 years or more may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on affected areas over the past 8 years
Not Eligible

You will not qualify if you...

  • Primarily "diffuse" type of AA characterized by diffuse hair shedding
  • Currently experiencing other forms of alopecia including trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or other conditions interfering with study evaluations
  • Largely or wholly incapacitated with little or no self-care ability, such as being bedridden
  • Uncontrolled arterial hypertension
  • Major surgery within 8 weeks prior to screening or planned major surgery during the study
  • History or presence of serious or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders
  • Positive test for hepatitis B virus infection
  • Hepatitis C virus infection confirmed by RNA presence
  • Evidence of HIV infection or positive HIV antibodies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 127 locations

1

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Not Yet Recruiting

3

Investigate MD

Scottsdale, Arizona, United States, 85255

Actively Recruiting

4

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

Not Yet Recruiting

5

Dermatology Research Associates

Los Angeles, California, United States, 90045

Actively Recruiting

6

University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

San Diego, California, United States, 92123

Actively Recruiting

7

The Permanente Medical Group, Inc.

San Francisco, California, United States, 94118

Actively Recruiting

8

Southern California Dermatology, Inc.

Santa Ana, California, United States, 92701

Actively Recruiting

9

Dermatology Physicians of Connecticut

Fairfield, Connecticut, United States, 06824

Not Yet Recruiting

10

Skin Care Research, Inc

Boca Raton, Florida, United States, 33486

Not Yet Recruiting

11

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, United States, 33134

Completed

12

D&H Doral Research Center LLC

Doral, Florida, United States, 33122

Not Yet Recruiting

13

Skin Care Research, Inc

Hollywood, Florida, United States, 33021

Not Yet Recruiting

14

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, United States, 32256

Actively Recruiting

15

University of Miami Miller School of Medicine

Miami, Florida, United States, 33125

Not Yet Recruiting

16

Pediatric Skin Research, LLC

Miami, Florida, United States, 33156

Actively Recruiting

17

Skin Care Physicians of Georgia

Macon, Georgia, United States, 31217

Actively Recruiting

18

Northwestern University

Chicago, Illinois, United States, 60611

Not Yet Recruiting

19

Northshore University Healthsystem

Skokie, Illinois, United States, 60077

Actively Recruiting

20

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Actively Recruiting

21

The South Bend Clinic Center for Research

South Bend, Indiana, United States, 46617

Actively Recruiting

22

DermAssociates PC.

Rockville, Maryland, United States, 20850

Actively Recruiting

23

Michigan Center for Research Company

Clarkston, Michigan, United States, 48346

Actively Recruiting

24

University of Minnesota Medical School

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

25

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

Actively Recruiting

26

Advanced Skin Research Center

Omaha, Nebraska, United States, 68144

Actively Recruiting

27

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

28

Dermatology Specialists of Charlotte

Charlotte, North Carolina, United States, 28277

Actively Recruiting

29

OnSite Clinical Solutions

Charlotte, North Carolina, United States, 28277

Actively Recruiting

30

Bexley Dermatology Research

Bexley, Ohio, United States, 43209

Actively Recruiting

31

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Not Yet Recruiting

32

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Not Yet Recruiting

33

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

34

Northwest Dermatology Institute

Portland, Oregon, United States, 97210

Actively Recruiting

35

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, United States, 19341

Completed

36

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

37

International Clinical Research - Tennessee (IC Research)

Murfreesboro, Tennessee, United States, 37130

Actively Recruiting

38

Dermatology Treatment and Research Center

Dallas, Texas, United States, 75230

Not Yet Recruiting

39

Pediatric Dermatology of North Texas

Grapevine, Texas, United States, 76051

Actively Recruiting

40

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Actively Recruiting

41

Complete Dermatology

Sugar Land, Texas, United States, 77479

Actively Recruiting

42

University of Utah MidValley Dematology

Murray, Utah, United States, 84107

Not Yet Recruiting

43

Virginia Clinical Research

Norfolk, Virginia, United States, 23502

Actively Recruiting

44

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53715

Actively Recruiting

45

Psoriahue Medicina Interdisciplinaria

Buenos Aires, Argentina, C1425DKG

Actively Recruiting

46

Fundación Respirar

Buenos Aires, Argentina, C1426ABP

Actively Recruiting

47

Derma Internacional SA

Buenos Aires, Argentina

Actively Recruiting

48

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, Argentina, C1055AA0

Actively Recruiting

49

Instituto de Neumonología Y Dermatología

Ciudad Autonoma Buenos Aires, Argentina, C1425BEA

Actively Recruiting

50

Hospital Universitario Austral

Pilar, Argentina, 1629

Not Yet Recruiting

51

Centro Medico Privado de Reumatologia

SAN M. de Tucuman, Argentina, T4000AXL

Completed

52

Hospital del Niño Jesus

San Miguel de Tucumán, Argentina, 4000

Actively Recruiting

53

Skin and Cancer Foundation Australia - Darlinghurst Clinic

Darlinghurst, Australia, 2010

Completed

54

Sinclair Dermatology

Melbourne, Australia, 3002

Actively Recruiting

55

Institute for Skin, Health, and Immunity

Mitcham, Australia, 3132

Actively Recruiting

56

Veracity Clinical Research Pty Ltd

Wooloongabba, Australia, 4102

Actively Recruiting

57

Dermatology Research Institute

Calgary, Canada, T2J 7E1

Actively Recruiting

58

Skin Health

Cobourg, Canada, K9A 0Z4

Actively Recruiting

59

Lynderm Research Inc.

Markham, Canada, L3P 1X2

Actively Recruiting

60

Dr. Chih-ho Hong Medical Inc.

Surrey, Canada, V3R 6A7

Actively Recruiting

61

Research Toronto

Toronto, Canada, M4W 2N2

Actively Recruiting

62

Wiseman Dermatology Research Inc.

Winnipeg, Canada, R3M 3Z4

Actively Recruiting

63

CHRU de Brest - Hôpital Morvan

Brest, France, 29609

Not Yet Recruiting

64

AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques

Marseille, France, 13005

Actively Recruiting

65

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, France, 44093

Actively Recruiting

66

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, France, 06202

Actively Recruiting

67

Centre de Sante Sabouraud

Paris, France, 75010

Actively Recruiting

68

Hôpital Clocheville Chru-Tours Département Dermatologie

Tours, France, 37044

Actively Recruiting

69

Fachklinik Bad Bentheim

Bad Bentheim, Germany, 48455

Actively Recruiting

70

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, Germany, 10117

Actively Recruiting

71

Universitätsklinikum Carl Gustav Carus

Dresden, Germany, 01307

Actively Recruiting

72

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Germany, 60590

Actively Recruiting

73

Kath. Kinderkrankenhaus Wilhelmstift

Hamburg, Germany, 22149

Actively Recruiting

74

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, Germany, 55128

Actively Recruiting

75

Klinikum Rechts der Isar der TU München

München, Germany, 80802

Not Yet Recruiting

76

University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology

Münster, Germany, 48149

Actively Recruiting

77

Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

Debrecen, Hungary, 4032

Completed

78

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary, 7400

Not Yet Recruiting

79

Pecsi Tudomanyegyetem

Pécs, Hungary, 7632

Actively Recruiting

80

Hamamatsu University Hospital

Hamamatsu, Japan, 431-3192

Actively Recruiting

81

Kurume University Hospital

Kurume, Japan, 830-0011

Actively Recruiting

82

Kyorin University Hospital

Mitaka, Japan, 181-8611

Actively Recruiting

83

Rifu Dermatology Allergy Clinic

Miyagi-gun, Japan, 981 0112

Actively Recruiting

84

Niigata University Medical & Dental Hospital

Niigata, Japan, 951-8520

Actively Recruiting

85

Osaka City University Hospital

Osaka, Japan, 545-8586

Actively Recruiting

86

Tokyo Medical University Hospital

Shinjuku-ku, Japan, 160-0023

Actively Recruiting

87

Yamaguchi University Hospital

Ube, Japan, 755-8505

Actively Recruiting

88

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Poland, 80-546

Actively Recruiting

89

CareClinic

Katowice, Poland, 40 568

Actively Recruiting

90

Centrum Medyczne Angelius Provita

Katowice, Poland, 40-611

Actively Recruiting

91

Gabinet Dermatologiczny

Kielce, Poland, 25-155

Actively Recruiting

92

Specjalistyczny Gabinet Dermatologiczny s.c.

Krakow, Poland, 30 002

Actively Recruiting

93

Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

Lodz, Poland, 90-436

Actively Recruiting

94

Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie

Rzeszów, Poland, 35 055

Actively Recruiting

95

DERMEDIC Jacek Zdybski

Swietokrzyski, Poland, 27 400

Actively Recruiting

96

Provita Poliklinika Sp. z o.o.

Warsaw, Poland, 02 647

Actively Recruiting

97

Royalderm Agnieszka Nawrocka

Warsaw, Poland, 02 962

Actively Recruiting

98

Centralny Szpital Kliniczny MSWiA

Warsaw, Poland, 02-507

Actively Recruiting

99

Centrum Medyczne Evimed

Warsaw, Poland, 02-625

Actively Recruiting

100

Klinika Ambroziak Sp. Z.O.O.

Warsaw, Poland, 02-953

Actively Recruiting

101

CityClinic Przychodnia Lekarsko-Psychologiczna

Wroclaw, Poland, 50-566

Actively Recruiting

102

Pusan National University Hospital

Busan, South Korea, 49241

Actively Recruiting

103

Dankook University Hospital

Cheonan-si, South Korea, 31116

Actively Recruiting

104

Chungnam national university hospital

Daejeon, South Korea, 35015

Actively Recruiting

105

Inha University Hospital

Incheon, South Korea, 22332

Actively Recruiting

106

Jeonbuk National University Hospital

Jeonju, South Korea, 54907

Actively Recruiting

107

Kyungpook National University Hospital

Junggu, South Korea, 41944

Actively Recruiting

108

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Actively Recruiting

109

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

110

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, South Korea, 03312

Actively Recruiting

111

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

112

Konkuk University Medical Center

Seoul, South Korea, 05030

Actively Recruiting

113

Kyunghee University Hospital at Gangdong

Seoul, South Korea, 05278

Actively Recruiting

114

Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)

Seoul, South Korea, 06973

Actively Recruiting

115

Ajou University Hospital

Suwon, South Korea, 16499

Actively Recruiting

116

Hospital Universitario Germans Trias i Pujol

Badalona, Spain, 08916

Actively Recruiting

117

Parc de Salut Mar - Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

118

Hospital Universitario Basurto

Bilbao (Bizkaia), Spain, 48013

Completed

119

Clinica Pedro Jaen

Madrid, Spain, 28006

Completed

120

Hospital Universitario Infanta Leonor-INTERNAL MED

Madrid, Spain, 28031

Actively Recruiting

121

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Actively Recruiting

122

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan, 235

Not Yet Recruiting

123

Chung Shan Medical University Hospital

Taichung, Taiwan, 40201

Actively Recruiting

124

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Not Yet Recruiting

125

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

126

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Not Yet Recruiting

127

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan, 333

Not Yet Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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