NCT05591222

Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

Detailed description

Approximately 72 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 20. The maximum trial duration per participant is approximately 36 weeks including screening, the 24 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study. Acquired from Horizon in 2024.

Conditions

• Discoid Lupus Erythematosus

Interventions

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

Timeline

• Start date: 2022-12-29
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2022-10-24
• Last updated: 2025-10-21

Locations

68 sites across 11 countries: United States, Argentina, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Poland

Regulatory

• FDA-regulated drug study