Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

This study evaluates 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.

Key facts

Study ID

NCT04518995

Run by

Concert Pharmaceuticals

People needed

706

Starts

2020-11-23

Expected to finish

2022-04-19

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
• Willing to comply with the study visits and requirements of the study protocol.

You may not qualify if…

• 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.

Where it is running

• Kern Research, Inc. — Bakersfield, California, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• UC Irvine Dermatology Clinical Research Center — Irvine, California, United States
• Quest Dermatology Research — Northridge, California, United States
• Kaiser Permanente — Oakland, California, United States
• Kaiser Permanente South Sacramento — Sacramento, California, United States
• Kaiser Permanente — San Francisco, California, United States
• Colorado Center for Dermatology and Skin Surgery — Centennial, Colorado, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• Yale University, Church Street Research Unit — New Haven, Connecticut, United States
• Lenus Research & Medical Group, LLC — Sweetwater, Florida, United States
• Clinical Research Trials of Florida, Inc. — Tampa, Florida, United States
• Forward Clinical Trials Inc. — Tampa, Florida, United States
• Denova Research — Chicago, Illinois, United States
• Northwestern Memorial Hospital, Department of Dermatology — Chicago, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• DS Research — New Albany, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• DS Research — Louisville, Kentucky, United States
• Qualmedica Research LLC — Owensboro, Kentucky, United States
• Massachusetts General Hospital - Clinic — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Total Skin and Beauty Dermatology Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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