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
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Houston, Texas 77030
Principal Investigator: Stephen K. Tyring
Phone: 713-528-8818
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Tiffany Mayo
Phone: 205-502-9960
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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
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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
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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
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Phone: 305-243-8205
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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Phone: 2106921382
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6565 West Loop South Freeway
Bellaire, Texas 77401
Principal Investigator: Craig Teller
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Beverly, Massachusetts 01915
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Phone: 843-792-5858
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303 East Superior Street
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Clarkston, Michigan 48346
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Cleveland, Ohio 44012
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Dallas, Texas 75231
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920 North Hamilton Road
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Irvine, California 92697
949-824-5011
Principal Investigator: Natasha Mesinkovska
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Jacksonville, Florida
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Macon, Georgia 31217
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Mobile, Alabama 36608
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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
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Newnan, Georgia 30263
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200 Lothrop St
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Portland, Oregon 97210
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3303 Southwest Bond Avenue
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