A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
This is a two part, double-blind, randomized, multicenter study 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Actual Study Start Date: February 26, 2021
Actual Primary Completion Date: January 18, 2023
Estimated Study Completion Date: April 2023
Arm:
- Experimental: Part A, Period 1 - Low dose
- Experimental: Part A, Period 1 - High dose
- Experimental: Part A, Period 2 - Dose reduction from low dose
- Placebo Comparator: Part A, Period 2 - Drug discontinuation from low dose
- Experimental: Part A, Period 2 - Dose reduction from high dose
- Placebo Comparator: Part A, Period 2 - Drug discontinuation from high dose
- Experimental: Part B - Low dose
- Experimental: Part B - High dose
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 300 |
| Actual Study start date | 26 February 2021 |
| Estimated Study Completion Date |
01 April 2023 |