A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Completed · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.

Key facts

Study ID

NCT04784533

Run by

Concert Pharmaceuticals

People needed

317

Starts

2021-02-26

Expected to finish

2023-05-16

Last updated by the study team

2024-10-09

Who can join

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

You may qualify if…

• Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Center for Dermatology and Plastic Surgery/CCT Research — Scottsdale, Arizona, 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
• Quest Dermatology Research — Northridge, California, United States
• Kaiser Permanente — Oakland, California, United States
• Palmtree Clinical Research, Inc. — Palm Springs, 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, Inc. — Denver, Colorado, United States
• Yale University Church Street Research Unit — New Haven, Connecticut, United States
• Skin Care Research, LLC — Boca Raton, Florida, United States
• Skin Care Research, LLC — Hollywood, Florida, United States
• DeNova Research — Chicago, Illinois, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• DS Research — Louisville, Kentucky, United States
• Michigan Center for Research Company, LLC — Clarkston, Michigan, United States
• University of Minnesota Department of Dermatology — Minneapolis, Minnesota, United States
• Minnesota Clinical Study Center — New Brighton, Minnesota, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Skin Laser and Surgery Specialists of New Jersey — Hackensack, New Jersey, United States
• Darst Dermatology — Charlotte, North Carolina, United States
• Dermatology Specialists of Charlotte — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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