A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)

  • STATUS
    Recruiting
  • End date
    Mar 19, 2022
  • participants needed
    700
  • sponsor
    Concert Pharmaceuticals
Updated on 19 September 2021
areata alopecia

Summary

This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Details
Condition Alopecia Areata, Alopecia, Male Pattern Baldness, Hair Loss, areata alopecia
Treatment CTP-543, 8 mg BID, CTP-543, 12 mg BID, Placebo, BID
Clinical Study IdentifierNCT04518995
SponsorConcert Pharmaceuticals
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical presentation compatible with 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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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