Summary

for people ages 18-65 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

This study will evaluate the safety and efficacy of CTP-543 in adult patients with chronic, moderate to severe alopecia areata.

Official Title

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Details

This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Subjects will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.

Keywords

Alopecia AreataAlopeciaCTP-543CTP-543, 4 mgCTP-543, 8 mgCTP-543, 12 mg

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Irvine
    IrvineCalifornia92697United States
  • Contour Dermatology & Cosmetic Surgery Center
    Rancho MirageCalifornia92270United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Concert Pharmaceuticals
ID
NCT03137381
Phase
Phase 2
Study Type
Interventional
Last Updated