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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


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

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