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Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

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ClinicalTrials.gov Identifier: NCT03898479
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Brief Summary:
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CTP-543
Patients who previously completed a qualifying CTP-543 clinical trial
Drug: CTP-543
Once or twice daily dosing




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 52 weeks ]
  2. Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) [ Time Frame: 52 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
Criteria

Inclusion Criteria:

  • Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion Criteria:

  • Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
  • Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
  • Donation of blood at any point throughout the study and for 30 days after last dose of study medication

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): NCT03898479


Contacts
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Contact: Colleen E. Hamilton, MS 781-674-5228 chamilton@concertpharma.com

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Palmtree Clinical Research, Inc. Recruiting
Palm Springs, California, United States, 92262
Stanford University School of Medicine - Medical Dermatology Clinic Recruiting
Redwood City, California, United States, 94063
Kaiser Permanente Clinical Trials Unit Recruiting
San Francisco, California, United States, 94118
United States, Connecticut
Yale University Church Street Research Unit Recruiting
New Haven, Connecticut, United States, 06519
United States, Florida
Siperstein Dermatology Group Recruiting
Boynton Beach, Florida, United States, 33472
United States, Illinois
Northwestern Memorial Hospital, Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
United States, New Hampshire
ActivMed Practices & Research, Inc. Recruiting
Portsmouth, New Hampshire, United States, 03801
United States, North Carolina
Wake Forest University Health Sciences, Department of Dermatology Recruiting
Winston-Salem, North Carolina, United States, 27104
United States, Oregon
NW Dermatology Institute Recruiting
Portland, Oregon, United States, 97210
United States, Texas
Suzanne Bruce and Associates, PA Recruiting
Houston, Texas, United States, 77056
Sponsors and Collaborators
Concert Pharmaceuticals

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03898479     History of Changes
Other Study ID Numbers: CP543.5001
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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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