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

• ClinicalTrials.gov Identifier: NCT05087628
• Recruitment Status: Recruiting
• First Posted: October 21, 2021
• Last Update Posted: March 30, 2023
• Sponsor: Provention Bio, Inc.
• Information provided by (Responsible Party): Provention Bio, Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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; Placebo

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Clinical Operations; 857-675-1664; info@proventionbio.com

Contact: Chief Medical Officer; 908-356-0514; info@proventionbio.com

Locations

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.

Investigators

• Study Director: Provention Bio, MD; Provention Bio, Inc.

More Information

• Responsible Party: Provention Bio, Inc.
• ClinicalTrials.gov Identifier: NCT05087628
• Other Study ID Numbers: PRV-3279-2a
• First Posted: October 21, 2021
• Last Update Posted: March 30, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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