PRV-3279 for Lupus

(PREVAIL-2 Trial)

No longer recruiting at 69 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called PRV-3279 to determine if it can safely and effectively prevent flare-ups in people with systemic lupus erythematosus (SLE), a disease where the immune system attacks healthy tissues. Participants will receive either the new treatment or a placebo, administered through an IV every four weeks, after corticosteroids (a type of anti-inflammatory drug) have improved their symptoms. The study seeks individuals who have had SLE for at least six months and continue to experience moderate to severe symptoms despite their usual medications. Those interested in exploring a new treatment option and meeting these criteria might find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop all lupus treatments except for antimalarials, corticosteroids (up to 10 mg of prednisone), and NSAIDs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PRV-3279 is generally well-tolerated. In earlier studies with healthy volunteers, PRV-3279 did not cause any serious side effects. Participants responded well to the treatment, indicating it can be safe for humans. These findings come from past studies where PRV-3279 demonstrated promising safety results.

PRV-3279 targets specific cells in the immune system without completely removing them, suggesting a lower risk of serious side effects related to immune system weakening.

These findings provide some reassurance about the safety of PRV-3279, although the current study will continue to monitor its safety in people with lupus. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard of care for lupus, which often includes corticosteroids and immunosuppressants, PRV-3279 is unique because it targets a specific part of the immune system. PRV-3279 is designed to modulate B cells, the immune cells involved in producing antibodies that attack the body's own tissues in lupus. This targeted approach aims to reduce disease activity while potentially minimizing the side effects associated with broader immune suppression. Researchers are excited about PRV-3279 because it could offer a more precise treatment option, improving outcomes for patients with fewer side effects.

What evidence suggests that this trial's treatments could be effective for lupus?

Research has shown that PRV-3279, which participants in this trial may receive, might help treat systemic lupus erythematosus (SLE) by preventing symptom flare-ups. Earlier studies found that PRV-3279 was generally safe and did not cause serious side effects. It targets specific parts of B cells, immune cells, to help reduce the immune response that can lead to SLE flare-ups. Initial results suggest it is both safe and effective, making PRV-3279 a promising option for further testing in lupus treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05087628

NCT05087628 | PRV-3279-2a Trial in Systemic Lupus 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 ...

2. news.sanofi.us news.sanofi.us/2020-03-12-Provention-Announces-Positive-Data-from-Phase-1b-PREVAIL-Study-of-PRV-3279

Provention Announces Positive Data from Phase 1b ... PRV-3279 may therefore, ultimately strike an optimal balance between safety and efficacy in lupus and other B cell-mediated autoimmune disorders ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/provention-bio-systemic-lupus-erythematosus/

Provention Bio begins systemic lupus erythematosus ... The proof-of-concept (POC) PRV-3279 EVAluation In Lupus- Phase 2 (PREVAIL-2) study will examine PRV-3279's efficacy and safety against placebo.

4. acrabstracts.org acrabstracts.org/abstract/prevail-1-a-multiple-ascending-dose-study-in-normal-healthy-volunteers-of-prv-3279-a-novel-bispecific-dart-molecule-targeting-cd32b-and-cd79b-on-b-cells-with-potential-for-treatment-of-sle/

PREVAIL 1: A Multiple Ascending Dose Study in Normal ... Results: PRV-3279 was well-tolerated, with no serious adverse events (Table 1). Pharmacokinetic (Table 2) and pharmacodynamic parameters were dose-dependent ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10808868/

Immunotherapeutic approaches for systemic lupus ... Current available data have demonstrated that PRV-3279 was well-tolerated and reduced immune response by inhibitory pathway in a phase Ia ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05087628

NCT05087628 | PRV-3279-2a Trial in Systemic Lupus 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05087628?tab=history&a=28

PRV-3279-2a Trial in Systemic Lupus (PREVAIL-2) 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 ...