Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus (PREVAIL-2)

Details

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.

Keywords

Systemic Lupus Erythematosus, SLE, PRV-3279

Eligibility

You can join if…

Open to people ages 18-70

  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

You CAN'T join if...

  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.

Locations

  • Clinical Site
    Los Angeles California 90095 United States
  • Clinical Site
    Mission Hills California 91345 United States
  • Clinical Site
    Tujunga California 91042 United States
  • Clinical Site
    Whittier California 90602 United States
  • Clinical Site
    Covina California 91722 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Provention Bio, a Sanofi Company
Links
Sign up for this study
ID
NCT05087628
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated