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Study of VIB7734 for the Treatment of Moderate to Severely Active SLE | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus

NCT04925934•Amgen

View on ClinicalTrials.gov

Summary

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years to ≤ 70 years
•Willing and able to understand and provide written informed consent.
•Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
•Disease duration of at least 6 months
•Active SLE as indicated by presence of all the following:
•1. SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
•2. SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
•3. At least one of the following BILAG 2004 Index levels of disease at Screening:
•BILAG A disease in ≥ 1 organ system
•BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening
+9 more criteria

Exclusion Criteria

•Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)
•History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy
•Active LN or active severe or unstable neuropsychiatric SLE
•Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome
•Participation in another clinical study with an investigational drug within 4 weeks before Day 1
•Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
•Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
•Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening
•Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection
•Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection
+4 more criteria

Locations (67)

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

IRIS Research and Development LLC

Plantation, Florida, United States

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Bluegrass Community Research Inc

Lexington, Kentucky, United States

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, United States

Feinstein Institute For Medical Research

Manhasset, New York, United States

SUNY Upstate Medical Center

Syracuse, New York, United States

Key Dates

Start Date

May 28, 2021

Primary Completion Date

May 16, 2023

Completion Date

June 9, 2023

Last Updated

July 23, 2024

Enrollment

214

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

VIB7734

DRUG

Placebo

OTHER

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NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases