PRV-3279 for Lupus (PREVAIL-2 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Provention Bio, a Sanofi Company

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people who've had systemic lupus erythematosus (SLE) for at least 6 months and meet specific criteria showing active disease despite treatment. They must have improved after steroids before joining, can't be on certain other lupus treatments, and should not have severe kidney or brain SLE symptoms, recent serious infections, COVID-19 recently, or been in another study or received certain vaccines too close to the start of this trial.

Inclusion Criteria

My condition is still severe despite taking my regular medication.

Exclusion Criteria

I haven't been in a drug study for at least 42 days or five half-lives of the drug.

I have a significant immune system disorder.

I have active kidney issues or brain symptoms due to lupus.

I haven't taken any biologic treatments like TNF inhibitors or interleukin antagonists in the last 42 days.

Treatment Details

The PREVAIL-2 study is testing PRV-3279 against a placebo to see if it can prevent flares in SLE patients whose symptoms got better with corticosteroids. Participants will either receive PRV-3279 or a placebo without knowing which one they're getting.

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Sterile solution for intravenous administration, every 4 weeks

Group II: PRV-3279Experimental Treatment1 Intervention

Sterile solution for intravenous administration, every 4 weeks

Corticosteroid is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Singulair for: