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Study to Evaluate the Safety and Efficacy of CTP-543 in Adults 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.
 
ClinicalTrials.gov Identifier: NCT03137381
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: CTP-543 Drug: CTP-543 matching 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. Participants 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: Cohort 1: CTP-543 4 mg BID
Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.
Drug: CTP-543
Administered as tablets.

Experimental: Cohort 2: CTP-543 8 mg BID
Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.
Drug: CTP-543
Administered as tablets.

Experimental: Cohort 3: CTP-543 12 mg BID
Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.
Drug: CTP-543
Administered as tablets.

Placebo Comparator: Combined Placebo
Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
Drug: CTP-543 matching placebo
Administered as tablets.




Primary Outcome Measures :
  1. Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 [ Time Frame: Week 24 ]
    The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24.

  2. Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: From first dose of study drug up to safety follow up at Week 28 ]
    An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.



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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
Criteria

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 Severity of Alopecia Tool (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 ClinicalTrials.gov identifier (NCT number): NCT03137381


Locations
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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
Investigators
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Study Director: Colleen E. Hamilton Concert Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Concert Pharmaceuticals:
Study Protocol  [PDF] January 21, 2019
Statistical Analysis Plan  [PDF] May 7, 2019

Publications:
Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 2019 American Academy of Dermatology Meeting; 01-05 March 2019; Washington, DC. Abstract 11291.
Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 11th World Congress Hair Research; 24-27 April 2019; Sitges, Barcelona.
Cassella J, Hamilton C, von Hehn J, Braman V. CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate to severe alopecia areata. In: Proceedings from the 28th EADV Congress; 09-13 October 2019, Madrid, Spain. D3T01.1: Late breaking news.

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03137381    
Other Study ID Numbers: CP543.2001
First Posted: May 2, 2017    Key Record Dates
Results First Posted: July 19, 2022
Last Update Posted: July 19, 2022
Last Verified: June 2022
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
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical