NCT04058028

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

Detailed description

This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators. Previous biologic use is allowed with an adequate washout period.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	Rozibafusp Alfa	Rozibafusp Alfa will be presented in 5 mL glass vial
DRUG	Placebo for Rozibafusp Alfa	Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Timeline

• Start date: 2020-02-19
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2019-08-15
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

147 sites across 19 countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain

Regulatory

• FDA-regulated drug study