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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03137381
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
Concert Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: CTP-543 Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : July 8, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CTP-543, 4 mg
Oral tablet, dosed twice-daily
Drug: CTP-543

Experimental: CTP-543, 8 mg
Oral tablet, dosed twice-daily
Drug: CTP-543

Experimental: CTP-543, 12 mg
Oral tablet, dosed twice-daily
Drug: CTP-543

Placebo Comparator: Placebo
Oral tablet, dosed twice daily
Drug: Placebo

Primary Outcome Measures :
  1. Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) [ Time Frame: 24 weeks ]
  2. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03137381

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United States, California
University of California, Irvine
Irvine, California, United States, 92697
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, United States, 92270
Stanford University School of Medicine
Redwood City, California, United States, 94064
Kaiser Permanente Northern California
San Francisco, California, United States, 94118
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Siperstein Dermatology Group
Boynton Beach, Florida, United States, 33472
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New York
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Northwest Dermatology
Portland, Oregon, United States, 97210
United States, Texas
Suzanne Bruce & Associates, PA
Houston, Texas, United States, 77056
Sponsors and Collaborators
Concert Pharmaceuticals
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Study Director: Ginny Braman Concert Pharmaceuticals, Inc.
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Responsible Party: Concert Pharmaceuticals Identifier: NCT03137381    
Other Study ID Numbers: CP543.2001
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical