A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

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Brief Title

A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Official Title

A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Brief Summary

      This is a two part, double-blind, randomized, multicenter study to evaluate the regrowth of
      hair with CTP-543 and subsequent durability of that regrowth following dose reduction in
      adult patients with moderate to severe alopecia areata.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction

Secondary Outcome

 Percentage of patients achieving loss of maintenance criteria following dose reduction

Condition

Alopecia Areata

Intervention

CTP-543

Study Arms / Comparison Groups

 Part A, Period 1 - Low dose
Description:  8 mg BID CTP-543 for 24 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

300

Start Date

February 26, 2021

Completion Date

April 2023

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Definitive diagnosis of alopecia areata with a current episode of scalp hair loss
             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.

          -  Willing to comply with the study visits and requirements of the study protocol.

        Exclusion Criteria:

          -  Treatment with other medications or agents within 1 month of Baseline or during the
             study that may affect hair regrowth or immune response.

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or other scalp condition that
             may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the
             body at Screening and/or Baseline.

          -  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.

          -  Females who are nursing, pregnant, or planning to become pregnant while in the study,
             and for 30 days after last dose of study drug.

          -  Clinically significant medical condition, psychiatric disease, or social condition, as
             determined by the Investigator, that may unfavorably alter the risk-benefit of study
             participation, adversely affect study compliance, or confound interpretation of study
             results.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 781-860-0045, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04784533

Organization ID

CP543.2004


Responsible Party

Sponsor

Study Sponsor

Concert Pharmaceuticals


Study Sponsor

, , 


Verification Date

April 2021