PRV-3279-2a Trial in Systemic Lupus

NCT05087628 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: PRV-3279-2aACT18113
• Study Type: interventional
• Target: 28
• Locations: 4 countries
• Sites: 36

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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

  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

  24 weeks

Secondary Outcomes (2)

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

  24 weeks

• To evaluate the safety of PRV-3279

  32 weeks

Study Arms (2)

PRV-3279

EXPERIMENTAL

Sterile solution for intravenous administration, every 4 weeks

Biological: PRV-3279

Placebo

EXPERIMENTAL

Sterile solution for intravenous administration, every 4 weeks

Other: Placebo

Interventions

PRV-3279 BIOLOGICAL

Bi-specific antibody-based molecule

Also known as: SAR446811

PRV-3279

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Provention Bio, a Sanofi Company: lead

Study Sites (36)

Medvin Clinical Research - Apple Valley- Site Number : 133

Apple Valley, California, 92307, United States

Location

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

Covina, California, 91722, United States

Location

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

La Jolla, California, 92037, United States

Location

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

Los Angeles, California, 90095, United States

Location

Facey Medical Group - Los Angeles- Site Number : 126

Los Angeles, California, 91345, United States

Location

Desert Medical Advances- Site Number : 114

Rancho Mirage, California, 92270, United States

Location

Medvin Clinical Research - Tujunga- Site Number : 119

Tujunga, California, 91042, United States

Location

Medvin Clinical Research - Whittier- Site Number : 118

Whittier, California, 90602, United States

Location

Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116

Avon Park, Florida, 33825, United States

Location

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

Fort Lauderdale, Florida, 33309, United States

Location

Millennium Research- Site Number : 111

Ormond Beach, Florida, 32174, United States

Location

D&H Tamarac Research Center- Site Number : 123

Tamarac, Florida, 33321, United States

Location

Florida Hospital Tampa- Site Number : 107

Tampa, Florida, 33613, United States

Location

Vernon Hills Medical Associates- Site Number : 128

Vernon Hills, Illinois, 60061, United States

Location

Ochsner Medical Center - Jefferson Highway- Site Number : 113

New Orleans, Louisiana, 70121, United States

Location

Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124

Troy, Michigan, 48084, United States

Location

University of Toledo Medical Center- Site Number : 110

Toledo, Ohio, 43614, United States

Location

Yale University School of Medicine- Site Number : 125

Pittsburgh, Pennsylvania, 15213-2536, United States

Location

Grapevine Rheumatology Clinic- Site Number : 103

Grapevine, Texas, 76051, United States

Location

Accurate Clinical Management - Greenhouse Road- Site Number : 104

Houston, Texas, 77084, United States

Location

Accurate Clinical Research - Houston Resource Parkway- Site Number : 105

Houston, Texas, 77089, United States

Location

Sun Research Institute- Site Number : 121

San Antonio, Texas, 78215, United States

Location

Investigational Site Number : 310

Beijing, 100050, China

Location

Investigational Site Number : 301

Beijing, 100730, China

Location

Investigational Site Number : 309

Changchun, 130021, China

Location

Investigational Site Number : 302

Guangzhou, 510080, China

Location

Investigational Site Number : 303

Nanchang, 330006, China

Location

Investigational Site Number : 307

Nanjing, 210008, China

Location

Investigational Site Number : 306

Shanghai, 200127, China

Location

Investigational Site Number : 305

Tianjin, 300052, China

Location

Investigational Site Number : 304

Wuhan, 430030, China

Location

Investigational Site Number : 202

Pok Fu Lam, 999077, Hong Kong

Location

Investigational Site Number : 201

Tuenmen, 999077, Hong Kong

Location

Centro Reumatologico de Caguas- Site Number : 112

Caguas, 00725, Puerto Rico

Location

Private Practice - Dr. Karina Vila Rivera- Site Number : 117

San Juan, 00917, Puerto Rico

Location

BCR Medical Center Inc.- Site Number : 129

San Juan, 909, Puerto Rico

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 21, 2021
• Study Start: January 24, 2022
• Primary Completion: May 14, 2024
• Study Completion: June 24, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); CN (9); PR (3); US (22)