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

Concert Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: CTP-543; Drug: CTP-543 matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04797650

2021-000387-30 (EudraCT Number)

CP543.3002

Details and patient eligibility

About

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.

Enrollment: 517 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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517 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.

Treatment:

Drug: CTP-543 matching placebo

CTP-543 8 mg BID

Experimental group

Description:

Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.

Treatment:

Drug: CTP-543

CTP-543 12 mg BID

Experimental group

Description:

Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.

Treatment:

Drug: CTP-543