PRV-3279-2a Trial in Systemic Lupus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid treatment.

Key facts

Study ID

NCT05087628

Run by

Provention Bio, a Sanofi Company

People needed

28

Starts

2022-01-20

Expected to finish

2024-06-24

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of SLE for at least 6 months prior to the Screening visit
• Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
• 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
• Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs

You may not qualify if…

• Active lupus nephritis or active central nervous system manifestations of SLE
• Other inflammatory or autoimmune diseases that, in the opinion of the Investigator or CAC, may confound efficacy evaluations
• Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency
• Known COVID-19 infection in the 4 weeks before Screening or positive SARS-CoV-2 RNA test
• 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
• Any recent infection requiring antibiotics within two weeks of Screening or any recent infection requiring IV antibiotics or hospitalization within 1 month of Screening
• 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
• Participated in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product, whichever is longer
• 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.
• 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.
• Received IV immunoglobulin (IVIG) or IV cyclophosphamide within 2 months, prednisone ≥ 100 mg/day for more than 30 days within 2 months, or plasmapheresis within two months of the Screening visit.

Where it is running

• 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
• Millennium Research- Site Number : 111 — Ormond Beach, Florida, United States
• D&H Tamarac Research Center- Site Number : 123 — Tamarac, Florida, United States
• Florida Hospital Tampa- Site Number : 107 — Tampa, Florida, United States
• Vernon Hills Medical Associates- Site Number : 128 — Vernon Hills, Illinois, United States
• Ochsner Medical Center - Jefferson Highway- Site Number : 113 — New Orleans, Louisiana, United States
• Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124 — Troy, Michigan, United States
• University of Toledo Medical Center- Site Number : 110 — Toledo, Ohio, United States
• Yale University School of Medicine- Site Number : 125 — Pittsburgh, Pennsylvania, United States
• Grapevine Rheumatology Clinic- Site Number : 103 — Grapevine, Texas, United States
• Accurate Clinical Management - Greenhouse Road- Site Number : 104 — Houston, Texas, United States
• Accurate Clinical Research - Houston Resource Parkway- Site Number : 105 — Houston, Texas, United States
• Sun Research Institute- Site Number : 121 — San Antonio, Texas, United States
• Investigational Site Number : 310 — Beijing, China
• Investigational Site Number : 301 — Beijing, China
• Investigational Site Number : 309 — Changchun, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.