PRV-3279-2a Trial in Systemic Lupus

Systemic Lupus Erythematosus Clinical Trial

— PREVAIL-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05087628
• Other study ID #: PRV-3279-2a
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 24, 2022
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• PRV-3279
Bi-specific antibody-based molecule

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
China	Clinical Site	Beijing	Beijing
China	Clinical Site	Beijing	Beijing
China	Clinical Site	Changchun	Jilin
China	Clinical Site	Nanchang	Jiangxi
China	Clinical Site	Nanjing	Jiangsu
China	Clinical Site	Shanghai	Shanghai
China	Clinical Site	Tianjin
China	Clinical Site	Wuhan	Hubei
Hong Kong	Clinical Site	Hong Kong
Hong Kong	Clinical Site	Hongkong
Puerto Rico	Clinical Site	Caguas
Puerto Rico	Clinical Site	San Juan
Puerto Rico	Clinical Site	San Juan
United States	Clinical Site	Apple Valley	California
United States	Clinical Site	Avon Park	Florida
United States	Clinical Site	Covina	California
United States	Clinical Site	Doral	Florida
United States	Clinical Site	Fort Lauderdale	Florida
United States	Clinical Site	Grapevine	Texas
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Houston	Texas
United States	Clinical Site	La Jolla	California
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Mission Hills	California
United States	Clinical Site	New Haven	Connecticut
United States	Clinical Cite	New Orleans	Louisiana
United States	Clinical Site	Ormond Beach	Florida
United States	Clinical Site	Rancho Mirage	California
United States	Clinical Site	San Antonio	Texas
United States	Clinical Site	Tamarac	Florida
United States	Clinical Site	Tampa	Florida
United States	Clinical Site	Toledo	Ohio
United States	Clinical Site	Tujunga	California
United States	Clinical Site	Vernon Hills	Illinois
United States	Clinical Site	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, a Sanofi Company

Countries where clinical trial is conducted

United States,  China,  Hong Kong,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	24 weeks
Secondary	To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids	Time to treatment failure	24 weeks
Secondary	To evaluate the safety of PRV-3279	Frequency of TEAEs, SAEs, TEAEs leading to drug withdrawal, AESIs	32 weeks