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Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With 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.
ClinicalTrials.gov Identifier: NCT03941548
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : March 11, 2021
Information provided by (Responsible Party):
Concert Pharmaceuticals

Brief Summary:
A randomized, multi-center study to evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: CTP-543 QD Dose Regimen Drug: CTP-543 BID Dose Regimen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CTP-543 QD Dose Regimen
Oral tablet for 24 Weeks
Drug: CTP-543 QD Dose Regimen
24 mg once-daily (QD)

Experimental: CTP-543 BID Dose Regimen
Oral tablet for 24 Weeks
Drug: CTP-543 BID Dose Regimen
12 mg twice-daily (BID)

Primary Outcome Measures :
  1. Relative change in Severity of Alopecia Tool (SALT) score for each dose regimen [ Time Frame: 24 Weeks ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 Weeks ]

Information from the National Library of Medicine

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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:

  • Clinical presentation compatible with 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.

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 within 3 months of screening or during the study, or biologics within 6 months of screening or during the study.
  • Clinical lab results outside the normal range.

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 ClinicalTrials.gov identifier (NCT number): NCT03941548

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United States, Colorado
Colorado Center for Dermatology and Skin Surgery
Centennial, Colorado, United States, 80111
United States, Florida
ForCare Clinical Research
Tampa, Florida, United States, 33613
United States, Indiana
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada, L4M 7G1
Guelph Dermatology Research
Guelph, Ontario, Canada, N1L 0B7
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, Canada, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
The Centre for Clinical Trials
Oakville, Ontario, Canada, L6J 7W5
Research Toronto
Toronto, Ontario, Canada, M4W 2N4
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2X 2V1
Sponsors and Collaborators
Concert Pharmaceuticals
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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03941548    
Other Study ID Numbers: CP543.2003
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021

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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