NCT05430854

Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Detailed description

Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab 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

• Systemic Lupus Erythematosus

Interventions

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

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2022-06-24
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

52 sites across 9 countries: United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain, Taiwan

Regulatory

• FDA-regulated drug study