Phase 2
N=317
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT04784533 ↗Enrolled (actual)
317
Serious AEs
1.8%
Results posted
Oct 2024
Primary outcome: Primary: Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction — 27.8; 32.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CTP-543 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Concert Pharmaceuticals
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction |
27.8; 32.0 | — |
| PRIMARY Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation |
83.3; 80.0 | — |
| PRIMARY Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 |
60.0; 50.0; 66.7; 73.7 | — |
| SECONDARY Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 |
0; 12; 6.3; 4.5; 0; 4.8 | — |
| SECONDARY Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 |
0; 16.7; 16.7; 14.3; 26.7; 43.8 | — |
| SECONDARY Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 |
24.0; 40.2; 26.9; 39.1; 25.6; 52.0 | — |
| SECONDARY Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 |
0; 0; 1.7; 2.3; 5.8; 16.4 | — |
| SECONDARY Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 |
-0.5; -1.0; -7.4; -14.8; -18.1; -30.9 | — |
| SECONDARY Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 |
26.7; 47.6; 37.7; 51.6; 47.6; 63.1 | — |
| SECONDARY Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 |
29.8; 52.8; 33.5; 55.5; 40.9; 63.4 | — |
| SECONDARY Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 |
6.4; 6.3; -0.8; -1.4; -1.1; -1.8 | — |
| SECONDARY Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 |
6.4; 6.4; -0.8; -1.1; -1.0; -1.6 | — |
| SECONDARY Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 |
4.6; 4.6; -0.9; -1.3; -1.0; -1.5 | — |
| SECONDARY Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 |
60.0; 62.5; 26.7; 15.8; 100.0; 62.5 | — |
| SECONDARY Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 |
-20.8; -1.5; 12.1; 47.8; -39.6; 26.2 | — |
| SECONDARY Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) |
124; 100; 9; 12; 7; 11 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT04784533). 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.