Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

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Brief Title

Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

Official Title

A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Brief Summary

      A randomized, multi-center study to evaluate the efficacy and tolerability of once-daily
      versus twice daily dosing of CTP-543, in adult patients with chronic, moderate to severe
      alopecia areata
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Relative change in Severity of Alopecia Tool (SALT) score for each dose regimen


Condition

Alopecia Areata

Intervention

CTP-543 QD Dose Regimen

Study Arms / Comparison Groups

 CTP-543 QD Dose Regimen
Description:  Oral tablet 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

57

Start Date

March 21, 2019

Completion Date

November 21, 2019

Primary Completion Date

November 21, 2019

Eligibility 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.

          -  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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Colleen E Hamilton, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03811912

Organization ID

CP543.2002


Responsible Party

Sponsor

Study Sponsor

Concert Pharmaceuticals


Study Sponsor

Colleen E Hamilton, MS, Study Director, Concert Pharmaceuticals, Inc.


Verification Date

December 2019