PRV-3279 for Lupus
(PREVAIL-2 Trial)
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PRV-3279 or placebo every 4 weeks for 20 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Corticosteroid
- Placebo
- PRV-3279
Corticosteroid is already approved in United States, European Union for the following indications:
- Asthma
- Exercise-induced bronchoconstriction
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
- Asthma
- Exercise-induced bronchoconstriction
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Provention Bio, a Sanofi Company
Lead Sponsor
Provention Bio, Inc.
Lead Sponsor