Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.