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
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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9897 Hagen Ranch Road
Boynton Beach, Florida 33472
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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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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 Haven, Connecticut 06520
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New Haven, CT
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New York, New York 10029
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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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