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Trial record 3 of 3 for:    CTP-543

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

This study is currently recruiting participants.
Verified October 2017 by Concert Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03137381
First Posted: May 2, 2017
Last Update Posted: October 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Concert Pharmaceuticals
  Purpose
This study will evaluate the safety and efficacy of CTP-543 in adult patients with chronic, moderate to severe alopecia areata.

Condition Intervention Phase
Alopecia Areata Drug: CTP-543 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Concert Pharmaceuticals:

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

Estimated Enrollment: 90
Actual Study Start Date: August 9, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CTP-543, 4 mg
Oral tablet, dosed twice-daily
Drug: CTP-543
tablets
Experimental: CTP-543, 8 mg
Oral tablet, dosed twice-daily
Drug: CTP-543
tablets
Experimental: Placebo
Oral tablet, dosed twice-daily
Drug: Placebo
tablets

Detailed Description:
This is a double-blind, randomized, placebo-controlled multi-center study consisting of 2 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.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (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 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.
  • Clinical lab results within the normal range
  • 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
  Contacts and Locations
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


Contacts
Contact: Jana von Hehn, PhD 781-860-0045 jvonhehn@concertpharma.com

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contour Dermatology & Cosmetic Surgery Center Recruiting
Rancho Mirage, California, United States, 92270
Stanford University School of Medicine Recruiting
Redwood City, California, United States, 94064
Kaiser Permanente Northern California Recruiting
San Francisco, California, United States, 94118
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
United States, New York
Icahn School of Medicine at Mt. Sinai Recruiting
New York, New York, United States, 10029
Columbia University Not yet recruiting
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
Northwest Dermatology Recruiting
Portland, Oregon, United States, 97210
United States, Texas
Suzanne Bruce & Associates, PA Recruiting
Houston, Texas, United States, 77056
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Study Director: Jana von Hehn, PhD Concert Pharmaceuticals, Inc.
  More Information

Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03137381     History of Changes
Other Study ID Numbers: CP543.2001
First Submitted: April 28, 2017
First Posted: May 2, 2017
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical