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

Systemic Lupus Erythematosus (SLE) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04058028
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 2
Start date February 19, 2020
Completion date July 25, 2023
View Details
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