PRV-3279 for Lupus (PREVAIL-2 Trial)

Phase 2

Waitlist Available

Research Sponsored by Provention Bio, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has moderate to severe disease activity despite stable standard-of-care medication

Be older than 18 years old

Must not have

Participation in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product

Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks

Summary

This trial is testing a drug to see if it can prevent flares in people with lupus who are in remission.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of PRV-3279 are not detailed here but generally could include reactions where the drug is given, increased risk of infection due to immune system changes, fatigue, headaches, and potential unknown risks as it's being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is still severe despite taking my regular medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a significant immune system disorder.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the ability of PRV-3279 to prevent flare, defined by LFA international consensus definition of flare, worsening on CGIC, and increase in hSLEDAI/BILAG scores

Secondary study objectives

To evaluate the safety of PRV-3279

To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids