Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata



Status:Active, not recruiting
Conditions:Dermatology, Dermatology, Hair Loss
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:1/25/2019
Start Date:August 9, 2017
End Date:August 31, 2019

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A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

This study will evaluate the safety and efficacy of CTP-543 in adult patients with chronic,
moderate to severe alopecia areata.

This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3
cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated
sequentially in ascending dose order. Subjects will be randomized to either an active dose of
CTP-543 or placebo for a 24-week treatment period.

Inclusion Criteria:

- Definitive diagnosis of alopecia areata with a current episode lasting at least 6
months and not exceeding 10 years at the time of Screening. Total disease duration
greater than 10 years is permitted.

- At least 50% scalp hair loss, as defined by a SALT score ≥50, at Screening and
Baseline.

- Clinical lab results within the normal range

Exclusion Criteria:

- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
treatment to the scalp, significant trauma to the scalp, or untreated actinic
keratosis on the scalp.

- Treatment with systemic immunosuppressive medications or biologics.

- Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening
or during the study
We found this trial at
13
sites
New Haven, Connecticut 06520
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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9897 Hagen Ranch Road
Boynton Beach, Florida 33472
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Boynton Beach, FL
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Fridley, Minnesota 55432
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Fridley, MN
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Houston, Texas 77056
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Houston, TX
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Irvine, CA
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New York, New York 10029
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New York, NY
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2330 Northwest Flanders Street
Portland, Oregon 97210
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Portland, OR
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Rancho Mirage, California 92270
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Rancho Mirage, CA
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Redwood City, California 94063
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Redwood City, CA
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San Francisco, California 94115
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San Francisco, CA
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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