PRV-3279-2a Trial in Systemic Lupus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Other: Placebo
- Registration Number
- NCT05087628
- Lead Sponsor
- Provention Bio, a Sanofi Company
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRV-3279 PRV-3279 Sterile solution for intravenous administration, every 4 weeks Placebo Placebo Sterile solution for intravenous administration, every 4 weeks
- Primary Outcome Measures
Name Time Method 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 24 weeks A flare is defined according to LFA international consensus definition of flare, worsening on Clinician's Global Impression of Change (CGIC), increases in hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)/British Isles Lupus Assessment Group (BILAG) Index scores
- Secondary Outcome Measures
Name Time Method To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids 24 weeks Time to treatment failure
To evaluate the safety of PRV-3279 32 weeks Frequency of TEAEs, SAEs, TEAEs leading to drug withdrawal, AESIs
Trial Locations
- Locations (36)
Investigational Site Number : 301
🇨🇳Beijing, China
Investigational Site Number : 309
🇨🇳Changchun, China
Investigational Site Number : 302
🇨🇳Guangzhou, China
Investigational Site Number : 303
🇨🇳Nanchang, China
Investigational Site Number : 307
🇨🇳Nanjing, China
Investigational Site Number : 306
🇨🇳Shanghai, China
Investigational Site Number : 305
🇨🇳Tianjin, China
Investigational Site Number : 304
🇨🇳Wuhan, China
Investigational Site Number : 202
🇭🇰Pok Fu Lam, Hong Kong
Investigational Site Number : 201
🇭🇰Tuen Mun, Hong Kong
Centro Reumatologico de Caguas- Site Number : 112
🇵🇷Caguas, Puerto Rico
Private Practice - Dr. Karina Vila Rivera- Site Number : 117
🇵🇷San Juan, Puerto Rico
BCR Medical Center Inc.- Site Number : 129
🇵🇷San Juan, Puerto Rico
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
Vernon Hills Medical Associates- Site Number : 128
🇺🇸Vernon Hills, Illinois, United States
Florida Hospital Tampa- Site Number : 107
🇺🇸Tampa, Florida, 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