PRV-3279-2a Trial in Systemic Lupus

Part of paid clinical trials in Apple Valley, California.

Sponsor
Provention Bio, a Sanofi Company
Study ID
NCT05087628
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PRV-3279 — BIOLOGICAL
    Bi-specific antibody-based molecule
  • Placebo — OTHER
    Placebo

Study Details

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 Dates

First listed
Oct 21, 2021
Start date
Jan 20, 2022
Status verified
Mar 2026
Primary completion
May 14, 2024
Completion
Jun 24, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRV-3279
    Sterile solution for intravenous administration, every 4 weeks
  • Experimental: Placebo
    Sterile solution for intravenous administration, every 4 weeks

Primary Outcome Measure

Percentage of Participants Who Maintained the Improvement in Systemic Lupus Erythematosus (SLE) Disease Activity From Baseline to Week 24 [ Time Frame: Baseline (Day 1) to Week 24 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Medvin Clinical Research - Apple Valley- Site Number : 133Apple ValleyCalifornia92307-
Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 106CovinaCalifornia91722-
University of California San Diego - La Jolla- Site Number : 108La JollaCalifornia92037-
Facey Medical Group - Los Angeles- Site Number : 126Los AngelesCalifornia91345-
University of California Los Angeles Medical Center- Site Number : 122Los AngelesCalifornia90095-
Desert Medical Advances- Site Number : 114Rancho MirageCalifornia92270-
Medvin Clinical Research - Tujunga- Site Number : 119TujungaCalifornia91042-
Medvin Clinical Research - Whittier- Site Number : 118WhittierCalifornia90602-
Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116Avon ParkFlorida33825-
Center for Rheumatology, Immunology and Arthritis- Site Number : 109Fort LauderdaleFlorida33309-
Millennium Research- Site Number : 111Ormond BeachFlorida32174-
D&H Tamarac Research Center- Site Number : 123TamaracFlorida33321-
Florida Hospital Tampa- Site Number : 107TampaFlorida33613-
Vernon Hills Medical Associates- Site Number : 128Vernon HillsIllinois60061-
Ochsner Medical Center - Jefferson Highway- Site Number : 113New OrleansLouisiana70121-
Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124TroyMichigan48084-
University of Toledo Medical Center- Site Number : 110ToledoOhio43614-
Yale University School of Medicine- Site Number : 125PittsburghPennsylvania15213-2536-
Grapevine Rheumatology Clinic- Site Number : 103GrapevineTexas76051-
Accurate Clinical Management - Greenhouse Road- Site Number : 104HoustonTexas77084-
Accurate Clinical Research - Houston Resource Parkway- Site Number : 105HoustonTexas77089-
Sun Research Institute- Site Number : 121San AntonioTexas78215-

Find similar trials in Apple Valley, CA

Nationwide
Lupus (SLE) trialsRheumatology trialsAutoimmune disease trials
By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Medvin Clinical Research - Apple Valley· Apple Valley, CAMedvin Clinical Research - Covina - West San Bernardino Road· Covina, CAUniversity of California San Diego - La Jolla· La Jolla, CAFacey Medical Group - Los Angeles· Los Angeles, CAUniversity of California Los Angeles Medical Center· Los Angeles, CADesert Medical Advances· Rancho Mirage, CA

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