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Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

Phase 2
Active, not recruiting
Conditions
Alopecia Areata
Interventions
Registration Number
NCT03898479
Lead Sponsor
Concert Pharmaceuticals
Brief Summary

The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1000
Inclusion Criteria
  • Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
Exclusion Criteria
  • Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
  • Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
  • Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
CTP-543CTP-543Patients who previously completed a qualifying CTP-543 clinical trial
Primary Outcome Measures
NameTimeMethod
Number of Participants with Adverse Events as a Measure of Safety332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)332 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (89)

Total Skin and Beauty Dermatology Center

🇺🇸

Birmingham, Alabama, United States

Alliance Dermatology & MOHS Center

🇺🇸

Phoenix, Arizona, United States

Center for Dermatology and Plastic Surgery/CCT Research

🇺🇸

Scottsdale, Arizona, United States

Johnson Dermatology

🇺🇸

Fort Smith, Arkansas, United States

Northwest Arkansas Clinical Trials Center, PLLC

🇺🇸

Rogers, Arkansas, United States

Kern Research Inc.

🇺🇸

Bakersfield, California, United States

Hope Clinical Research

🇺🇸

Canoga Park, California, United States

California Dermatology & Clinical Research Institute

🇺🇸

Encinitas, California, United States

University of California, Irvine

🇺🇸

Irvine, California, United States

Dermatology Research Associates

🇺🇸

Los Angeles, California, United States

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Total Skin and Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States

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