Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata
Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata
Brief Summary:
The purpose of this study is to assess the preliminary efficacy, safety, tolerability, PK, and PD of Daxdilimab in participants with moderate to severe AA, with ≥50% and ≤95% total scalp hair loss as defined by the SALT score at Screening and Day 1.
Detailed Description:
Approximately 30 participants will be enrolled to receive daxdilimab administered subcutaneously over 32 weeks. The maximum trial duration per participant is approximately 52 weeks, including up to 30 days for the screening period, 32 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 16 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata
Actual Study Start Date: April 27, 2022
Estimated Primary Completion Date: August 25, 2023
Estimated Study Completion Date: January 29, 2024
Arm:
- Experimental: Daxdilimab
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 30 |
| Actual Study start date | 27 April 2022 |
| Estimated Study Completion Date | 06 June 2023 |