Phase 3
N=706
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT04518995 ↗Enrolled (actual)
706
Serious AEs
1.3%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 — 0.8; 29.6; 41.5 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CTP-543 matching placebo (Drug); CTP-543 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Concert Pharmaceuticals
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 |
0.8; 29.6; 41.5 | <0.0001 sig |
| SECONDARY Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 |
11.9; 35.3; 46.4; 8.3; 38.2; 51.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 |
0; 0.9; 0; 0; 3.3; 6.1 | 0.0816 |
| SECONDARY Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 |
-0.2; -2.6; -4.0; -2.3; -10.9; 17.5 | 0.0564 |
| SECONDARY Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 |
3.7; 36.3; 43.5; 7.7; 44.2; 54.7 | <0.0001 sig |
| SECONDARY Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 |
6.7; 38.9; 49.8; 9.0; 49.1; 58.3 | <0.0001 sig |
| SECONDARY Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 |
6.5; 6.4; 6.4; -0.1; -1.0; -1.4 | <0.0001 sig |
| SECONDARY Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 |
6.5; 6.5; 6.4; -0.4; -1.1; -1.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 |
0; 8.8; 17.7; 0; 28.6; 40.0 | <0.0001 sig |
| SECONDARY Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 |
1.7; 1.2; 1.4; -0.2; 0.8; 1.1 | 0.0010 sig |
| SECONDARY Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 |
1.5; 1.4; 1.7; -0.1; 0.9; 1.3 | <0.0001 sig |
| SECONDARY Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 |
4.5; 4.5; 4.5; -0.6; -1.3; -1.7 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 |
20.7; 44.7; 53.1; 14.3; 48.1; 53.9 | < 0.0001 sig |
| SECONDARY Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 |
4.5; 4.6; 4.5; -0.4; -1.1; -1.3 | <0.0001 sig |
| SECONDARY Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 |
5.5; 6.2; 6.0; -0.4; -1.0; -1.1 | 0.2489 |
| SECONDARY Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24 |
0; 20.8; 34.5 | <0.0001 sig |
Summary
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.
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.
- 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 (NCT04518995). 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.