Phase 2
N=66
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT03941548 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Apr 2023
Primary outcome: Primary: Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 — 58.44; 51.96 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
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 |
58.44; 51.96 | — |
| SECONDARY Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline |
0.0; 0.0; 0.0; 0.0; 8.8; 6.3 | — |
| SECONDARY Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 |
1.95; 3.02; 11.68; 13.61; 26.07; 25.33 | — |
| SECONDARY Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 |
3.12; 3.95; 14.57; 17.24; 32.10; 31.90 | — |
| SECONDARY Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline |
3.6; 0; 0; 0; 39.3; 44.8 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03941548). 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.