Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata

Concert Pharmaceuticals66 enrolled

Overview

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alopecia Areata

Interventions

CTP-543DRUG

Administered as 12 mg tablets.

CTP-543 Matching PlaceboDRUG

Administered as tablets to aid treatment masking.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp. * 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. * Clinical lab results outside the normal range.

Locations (12)

Colorado Center for Dermatology and Skin Surgery

Centennial, Colorado, United States

ForCare Clinical Research

Tampa, Florida, United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Outcomes

Primary Outcomes

Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24

The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).

Time frame: Baseline, Week 24

Secondary Outcomes

Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline

The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.

Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24

The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).

Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20

Time frame: Baseline, Weeks 4, 8, 12, 16 and 20

Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline

Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to Weeks 8, 12 and 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.

Data from ClinicalTrials.gov

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