Clinical trial NCT05087628: PRV-3279-2a Trial in Systemic Lupus
Official title: Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Systemic Lupus Erythematosus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.
11. 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.

Primary outcomes:
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
measure: To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids
timeFrame: 24 weeks
measure: To evaluate the safety of PRV-3279
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Apple Valley
country: United States
facility: Medvin Clinical Research - Apple Valley- Site Number : 133
state: California
city: Covina
country: United States
facility: Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 106
state: California
city: La Jolla
country: United States
facility: University of California San Diego - La Jolla- Site Number : 108
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center- Site Number : 122
state: California
city: Los Angeles
country: United States
facility: Facey Medical Group - Los Angeles- Site Number : 126
state: California
city: Rancho Mirage
country: United States
facility: Desert Medical Advances- Site Number : 114
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research - Tujunga- Site Number : 119
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Whittier- Site Number : 118
state: California
city: Avon Park
country: United States
facility: Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology and Arthritis- Site Number : 109
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research- Site Number : 111
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center- Site Number : 123
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa- Site Number : 107
state: Florida
city: Vernon Hills
country: United States
facility: Vernon Hills Medical Associates- Site Number : 128
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center - Jefferson Highway- Site Number : 113
state: Louisiana
city: Troy
country: United States
facility: Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124
state: Michigan
city: Toledo
country: United States
facility: University of Toledo Medical Center- Site Number : 110
state: Ohio
city: Pittsburgh
country: United States
facility: Yale University School of Medicine- Site Number : 125
state: Pennsylvania
city: Grapevine
country: United States
facility: Grapevine Rheumatology Clinic- Site Number : 103
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management - Greenhouse Road- Site Number : 104
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research - Houston Resource Parkway- Site Number : 105
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute- Site Number : 121
state: Texas
city: Beijing
country: China
facility: Investigational Site Number : 310
city: Beijing
country: China
facility: Investigational Site Number : 301
city: Changchun
country: China
facility: Investigational Site Number : 309
city: Guangzhou
country: China
facility: Investigational Site Number : 302
city: Nanchang
country: China
facility: Investigational Site Number : 303
city: Nanjing
country: China
facility: Investigational Site Number : 307
city: Shanghai
country: China
facility: Investigational Site Number : 306
city: Tianjin
country: China
facility: Investigational Site Number : 305
city: Wuhan
country: China
facility: Investigational Site Number : 304
city: Pok Fu Lam
country: Hong Kong
facility: Investigational Site Number : 202
city: Tuen Mun
country: Hong Kong
facility: Investigational Site Number : 201
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico de Caguas- Site Number : 112
city: San Juan
country: Puerto Rico
facility: Private Practice - Dr. Karina Vila Rivera- Site Number : 117
city: San Juan
country: Puerto Rico
facility: BCR Medical Center Inc.- Site Number : 129
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: