Phase 2 N=57 Randomized Triple-blind Treatment

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

Alopecia Areata

Bottom Line

View on ClinicalTrials.gov: NCT03811912 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 — 46.4; 18.0 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CTP-543 (Drug); CTP-543 Matching Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Concert Pharmaceuticals
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24	46.4; 18.0	—
SECONDARY Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline	0; 0; 0; 0; 3.4; 0	—
SECONDARY Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24	0.8; -0.8; 6.5; 2.1; 18.5; 5.3	—
SECONDARY Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20	1.4; -1.3; 8.6; 2.7; 23.7; 5.1	—
SECONDARY Percentage of Participants With Change in Satisfaction of Hair Coverage	0; 3.6; 3.4; 0; 55.2; 17.9	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Definitive diagnosis of 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.
Clinical lab results within the normal range

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 or biologics.
Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03811912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.