Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

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: NCT04797650
Run by: Concert Pharmaceuticals
People needed: 517
Starts: 2021-06-10
Expected to finish: 2022-06-29
Last updated by the study team: 2023-07-03

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

Johnson Dermatology — Fort Smith, Arkansas, United States
Dermatology Research Associates — Los Angeles, California, United States
University of Miami Hospital — Miami, Florida, United States
Floridian Research Institute LLC — Miami, Florida, United States
MetroBoston Clinical Partners, LLC — Brighton, Massachusetts, United States
Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
Hamzavi Dermatology — Fort Gratiot, Michigan, United States
Galen Research — Chesterfield, Missouri, United States
Vivida Dermatology — Las Vegas, Nevada, United States
The Dermatology Group P.C. — Verona, New Jersey, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Columbia University Medical Center - Department of Dermatology — New York, New York, United States
University of Rochester — Rochester, New York, United States
Dermatologists of Southwest Ohio — Mason, Ohio, United States
Oregon Medical Research — Portland, Oregon, United States
Velocity Clinical Research - Providence — Warwick, Rhode Island, United States
The Skin Wellness Center — Knoxville, Tennessee, United States
North Texas Center for Clinical Research — Frisco, Texas, United States
Elixir Research Group — Houston, Texas, United States
Progressive Clinical Research — San Antonio, Texas, United States
Velocity Clinical Research/Gateway — Salt Lake City, Utah, United States
Velocity Clinical Research/Swinyer-Woseth Dermatology — Salt Lake City, Utah, United States
Jordan Valley Dermatology Center — South Jordan, Utah, United States
The Rector and Visitors of the University of Virginia — Charlottesville, Virginia, United States
Alliance Dermatology & Mohs Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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