NCT05087628

PRV-3279-2a Trial in Systemic Lupus

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Provention Bio, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	PRV-3279	Bi-specific antibody-based molecule
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-05-14
• Completion: 2024-06-24
• First posted: 2021-10-21
• Last updated: 2026-04-03
• Results posted: 2026-04-03

Locations

36 sites across 4 countries: United States, China, Hong Kong, Puerto Rico

Regulatory

• FDA-regulated drug study