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Extension Study to Evaluate Safety and Efficacy 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: NCT03898479
Recruitment Status : Enrolling by invitation
First Posted : April 2, 2019
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Study Description
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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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
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 : February 2023
Estimated Study Completion Date : May 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CTP-543
Patients who previously completed a qualifying CTP-543 clinical trial
 Drug: CTP-543
Twice daily dosing


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 220 weeks ]
  2. Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) [ Time Frame: 220 weeks ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Concert Pharmaceuticals
More Information
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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03898479    
Other Study ID Numbers: CP543.5001
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022

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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