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PRV-3279-2a Trial in Systemic Lupus — PREVAIL-2  

Systemic Lupus Erythematosus Clinical Trial

Official title:
Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus (PREVAIL-2)

Clinical Trial Summary

The PREVAIL-2 study is designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) patients with active disease after amelioration induced by corticosteroid treatment.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study in adult patients with active SLE. Approximately 100 eligible patients will be randomized at a 1:1 ratio to receive treatment with either PRV-3279 or placebo. Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of SLE for at least 6 months. The study drug will be administered every 4 weeks for 20 weeks in a double-blind fashion, followed by an 8-week safety follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05087628
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 24, 2022
Completion date September 2025
View Details
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