NCT05540665

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants With Active Proliferative Lupus Nephritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).

Detailed description

Approximately 210 participants will be randomized to receive daxdilimab or placebo administered subcutaneously through Week 52 in addition to their standard of care background therapy (mycophenolate mofetil (MMF) and corticosteroids). At Week 64, all participants will be assigned to a quarterly dosing maintenance regimen of either daxdilimab or placebo based upon pre-defined renal response observed by Week 52. The maximum trial duration per participant is approximately 116 weeks including a 4-week screening period, the 104 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

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Daxdilimab	Daxdilimab will be administered subcutaneously as two injections for each dose. Other Names: HZN-7734
DRUG	Daxdilimab	Daxdilimab will be administered subcutaneously as two injections for each dose. Other Names: HZN-7734
DRUG	Placebo (Normal Saline)	Placebo will be administered subcutaneously as two injections for each dose.

Timeline

• Start date: 2023-04-26
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2022-09-15
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

52 sites across 12 countries: United States, Argentina, Brazil, Croatia, Israel, Malaysia, Philippines, Poland, Serbia, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study