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PRV-3279-2a Trial in Systemic Lupus (PREVAIL-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05087628
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : March 30, 2023
Information provided by (Responsible Party):
Provention Bio, Inc.

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.

Condition or disease Intervention/treatment Phase
Efficacy and Safety Biological: PRV-3279 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus (PREVAIL-2)
Actual Study Start Date : January 24, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: PRV-3279
Sterile solution for intravenous administration, every 4 weeks
Biological: PRV-3279
Bi-specific antibody-based molecule

Experimental: Placebo
Sterile solution for intravenous administration, every 4 weeks
Other: Placebo

Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids [ Time Frame: 24 weeks ]
    Time to treatment failure

  2. To evaluate the safety of PRV-3279 [ Time Frame: 32 weeks ]
    Frequency of TEAEs, SAEs, TEAEs leading to drug withdrawal, AESIs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087628

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Contact: Clinical Operations 857-675-1664 info@proventionbio.com
Contact: Chief Medical Officer 908-356-0514 info@proventionbio.com

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United States, California
Clinical Site Recruiting
Covina, California, United States, 91722
Clinical Site Recruiting
La Jolla, California, United States, 92037
Clinical Site Recruiting
Los Angeles, California, United States, 90095
Clinical Site Recruiting
Palm Desert, California, United States, 92260
Clinical Site Recruiting
Tujunga, California, United States, 91042
Clinical Site Recruiting
Whittier, California, United States, 90602
United States, Florida
Clinical Site Recruiting
Avon Park, Florida, United States, 33823
Clinical Site Recruiting
Doral, Florida, United States, 33122
Clinical Site Recruiting
Fort Lauderdale, Florida, United States, 33309
Clinical Site Recruiting
Ormond Beach, Florida, United States, 32174
Clinical Site Recruiting
Tamarac, Florida, United States, 33321
Clinical Site Completed
Tampa, Florida, United States, 33613
United States, Illinois
Clinical Site Recruiting
Vernon Hills, Illinois, United States, 60061
United States, Ohio
Clinical Site Recruiting
Toledo, Ohio, United States, 43614
United States, Texas
Clinical Site Active, not recruiting
Grapevine, Texas, United States, 76051
Clinical Site Recruiting
Houston, Texas, United States, 77084
Clinical Site Recruiting
Houston, Texas, United States, 77089
Clinical Site Recruiting
San Antonio, Texas, United States, 78215
Hong Kong
Clinical Site Recruiting
Hong Kong, Hong Kong
Puerto Rico
Clinical Site Recruiting
Caguas, Puerto Rico, 00725
Clinical Site Recruiting
San Juan, Puerto Rico, 00907
Clinical Site Recruiting
San Juan, Puerto Rico, 00917
Sponsors and Collaborators
Provention Bio, Inc.
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Study Director: Provention Bio, MD Provention Bio, Inc.
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Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT05087628    
Other Study ID Numbers: PRV-3279-2a
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No