A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata



Status:Recruiting
Conditions:Dermatology, Dermatology, Hair Loss
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 70
Updated:4/5/2019
Start Date:September 24, 2018
End Date:August 5, 2022
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

This study is designed to select up to two doses of baricitinib (referred to as low dose and
high dose) and assess their efficacy and safety for the treatment of severe or very severe
alopecia areata.


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).
We found this trial at
52
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Washington, District of Columbia 20060
Principal Investigator: Ginette Okoye
Phone: 202-865-4330
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Tiffany Mayo
Phone: 205-502-9960
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Maryanne Senna
Phone: 617-726-2914
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Arash Mostaghimi
Phone: 617-525-8335
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Steven Robert Cohen
Phone: 7189202176
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Wilma Bergfeld
Phone: 216-444-5725
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Antonella Tosti
Phone: 305-243-8205
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
Principal Investigator: Steven Andrew Davis
Phone: 2106921382
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6565 West Loop South Freeway
Bellaire, Texas 77401
Principal Investigator: Craig Teller
Phone: 832-553-2318
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Beverly, Massachusetts 01915
Principal Investigator: David S Greenstein
Phone: 978-969-6897
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lara Wine Lee
Phone: 843-792-5858
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Maria Colavincenzo
Phone: 312-503-5944
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Clarkston, Michigan 48346
Principal Investigator: Wendy McFalda
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Cleveland, Ohio 44012
Principal Investigator: Neil J Korman
Phone: 216-844-5197
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Dallas, Texas 75231
Principal Investigator: Jennifer A Cather
Phone: 214-361-2008
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Encinitas, California 92024
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Exton, Pennsylvania 19341
Principal Investigator: Scott L Gottlieb
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Fort Smith, Arkansas 72916
Principal Investigator: Sandra Johnson
Phone: 479-649-3376
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920 North Hamilton Road
Gahanna, Ohio 43230
Principal Investigator: Jessica Kaffenberger
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Glenn Dale, Maryland 20769
Principal Investigator: Valerie Callender
Phone: 301-249-0970
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Houston, Texas 77030
Principal Investigator: Stephen K. Tyring
Phone: 713-528-8818
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Irvine, California 92697
949-824-5011
Principal Investigator: Natasha Mesinkovska
Phone: 949-824-7103
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Jacksonville, Florida
Principal Investigator: Pearl Kwong
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Kurume, Fukuoka 83000
Principal Investigator: Norito Ishii
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Laguna Hills, California 92653
Principal Investigator: Kenneth Deck
Phone: 949-680-3490
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Los Angeles, California 90045
Principal Investigator: Howard L Sofen
Phone: 310-337-7171
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Louisville, Kentucky 40202
Principal Investigator: Cindy E Owen
Phone: 502-585-9059
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Macon, Georgia 31217
Principal Investigator: David J Cohen
Phone: 478-742-2180
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Minneapolis, Minnesota 55455
Principal Investigator: Maria K Hordinsky
Phone: 612-625-6118
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Mobile, Alabama 36608
Principal Investigator: Aldo Trovato
Phone: 251-414-1984
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243 6100 South
Murray, Utah 84107
Principal Investigator: Gerald G Krueger
Phone: 801-213-0375
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Brett A King
Phone: 203-577-1050
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Newnan, Georgia 30263
Principal Investigator: Mark R Ling
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Orange Park, Florida 32073
Principal Investigator: George Schmieder
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Principal Investigator: Edward Lain
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Philadelphia, Pennsylvania 19104
Principal Investigator: Susan Taylor
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200 Lothrop St
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Principal Investigator: Laura K Ferris
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Portland, Oregon 97210
Principal Investigator: Janet Roberts
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3303 Southwest Bond Avenue
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Principal Investigator: Teri Ms Greiling
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Portland, Oregon 97223
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Redwood City, California 94063
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