NCT05368103

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 acquired from Horizon in 2024.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
BIOLOGICAL	Daxdilimab	Daxdilimab will be administered subcutaneously as two injections for each dose.

Timeline

• Start date: 2022-04-27
• Primary completion: 2023-08-07
• Completion: 2024-01-26
• First posted: 2022-05-10
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study