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Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata

Alopecia Areata Clinical Trial

Official title:
A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata

Clinical Trial 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.

Clinical Trial 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 acquired from Horizon in 2024. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05368103
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 2
Start date April 27, 2022
Completion date January 25, 2024
View Details
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