A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care (TOPAZ-1)
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- STATUS
- Recruiting
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- End date
- Sep 29, 2025
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- participants needed
- 540
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- sponsor
- Biogen
Summary
The primary objective of this study is to demonstrate efficacy of BIIB059 compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.
Secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE; and to evaluate immunogenicity of BIIB059 in participants with active SLE.
Details
| Condition | Lupus Erythematosus, Systemic |
|---|---|
| Treatment | BIIB059, BIIB059 matching placebo |
| Clinical Study Identifier | NCT04895241 |
| Sponsor | Biogen |
| Last Modified on | 13 May 2022 |
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