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PRV-3279-2a Trial in Systemic Lupus | Clinical Trials | Clareo Health

TERMINATEDPHASE2

PRV-3279-2a Trial in Systemic Lupus

Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus

NCT05087628•Provention Bio, a Sanofi Company

Summary

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.

Detailed Description

This is a randomized, double-blind, placebo-controlled study in adult patients with active SLE. Approximately 100 eligible patients will be randomized at a 1:1 ratio to receive treatment with either PRV-3279 or placebo. Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of SLE for at least 6 months. The study drug will be administered every 4 weeks for 20 weeks in a double-blind fashion, followed by an 8-week safety follow-up period.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. A diagnosis of SLE for at least 6 months prior to the Screening visit
•2. Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
•3. Have moderate to severe disease activity despite stable standard-of-care medication defined as:
•At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement
•4. Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs

Exclusion Criteria

•1. Active lupus nephritis or active central nervous system manifestations of SLE
•2. Other inflammatory or autoimmune diseases that, in the opinion of the Investigator or CAC, may confound efficacy evaluations
•3. Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency
•4. Known COVID-19 infection in the 4 weeks before Screening or positive SARS-CoV-2 RNA test
•5. Received a live attenuated vaccine within 2 months of Screening, received a non-live or mRNA vaccine within 2 weeks of Screening, or expecting to receive any vaccine during the study period
•6. Any recent infection requiring antibiotics within two weeks of Screening or any recent infection requiring IV antibiotics or hospitalization within 1 month of Screening
•7. Any condition for which, in the opinion of the Investigator or CAC, participation in the study would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments
•8. Participated in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product, whichever is longer
•9. Received rituximab or equivalent treatment that depletes B cells within 6 months of Screening unless return of B cells to pre-treatment value or normal range can be demonstrated.
•10. Received tumor necrosis factor inhibitors, interleukin antagonists, or other biologics, including belimumab, within 42 days or five half-lives of the agent, whichever is longer.
+1 more criteria

Locations (36)

Medvin Clinical Research - Apple Valley- Site Number : 133

Apple Valley, California, United States

Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 106

Covina, California, United States

University of California San Diego - La Jolla- Site Number : 108

La Jolla, California, United States

University of California Los Angeles Medical Center- Site Number : 122

Los Angeles, California, United States

Facey Medical Group - Los Angeles- Site Number : 126

Los Angeles, California, United States

Desert Medical Advances- Site Number : 114

Rancho Mirage, California, United States

Medvin Clinical Research - Tujunga- Site Number : 119

Tujunga, California, United States

Medvin Clinical Research - Whittier- Site Number : 118

Whittier, California, United States

Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116

Avon Park, Florida, United States

Center for Rheumatology, Immunology and Arthritis- Site Number : 109

Fort Lauderdale, Florida, United States

Key Dates

Start Date

January 24, 2022

Primary Completion Date

May 14, 2024

Completion Date

June 24, 2024

Last Updated

May 8, 2025

Enrollment

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

PRV-3279

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PRV-3279-2a Trial in Systemic Lupus

Inclusion Criteria

Exclusion Criteria

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