Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Maureen A. McMahon, MD
Headshot of Maureen A. McMahon
Maureen A. McMahon

Description

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.

Official Title

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

Details

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.

Keywords

Systemic Lupus Erythematosus, SLE, PRV-3279

Eligibility

Locations

Lead Scientist at UCLA

  • Maureen A. McMahon, MD
    Dr. Maureen A. McMahon holds the Carl M. Pearson, M.D., Endowed Chair in Rheumatology.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Provention Bio, a Sanofi Company
Links
Sign up for this study
ID
NCT05087628
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated