PRV-3279 for Lupus

(PREVAIL-2 Trial)

Recruiting at 68 trial locations

Overseen By Director Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Provention Bio, a Sanofi Company

Must be taking: Antimalarials, Corticosteroids, NSAIDs

Must not be taking: Biologics, Rituximab, IVIG, Cyclophosphamide

Disqualifiers: Lupus nephritis, CNS manifestations, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 20 weeks

28 Participants Needed

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

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.

I have been diagnosed with SLE for at least 6 months.

I am willing to stop all my lupus treatments except for antimalarials, low-dose steroids, and NSAIDs.

Exclusion Criteria

I haven't taken antibiotics in the last 2 weeks or been hospitalized for an infection in the last month.

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

Nothing will stop me from following the study's required checks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PRV-3279 or placebo every 4 weeks for 20 weeks

20 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

Treatment Details

Interventions

• Corticosteroid
• Placebo
• PRV-3279

Trial Overview 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.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

Sterile solution for intravenous administration, every 4 weeks

Group II: PRV-3279 Experimental Treatment 1 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:

• Asthma
• Exercise-induced bronchoconstriction
• Seasonal allergic rhinitis
• Perennial allergic rhinitis

Approved in European Union as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Seasonal allergic rhinitis
• Perennial allergic rhinitis

Who Is Running the Clinical Trial?

Provention Bio, a Sanofi Company

Lead Sponsor

Trials

5

Recruited

540+

Provention Bio, Inc.

Lead Sponsor

Trials

11

Recruited

1,300+