A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

Zenas BioPharma (USA), LLC

Summary

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

Description

This study consists of a 24-week treatment period followed by a 12-week follow-up period. Patients must have a clinical diagnosis of SLE at least 24 weeks prior to screening and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria. To enter the Screening Period (Day -28 to Day -1) patients will have active SLE as defined by having: a) hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) ≥ 6 and clinical hSLEDAI ≥ 4, and b) British Isles Lupus Assessment Group (BILAG)-2004 Grade A or B in ≥ 1 organ system. Patien…

Eligibility

Age range: 18–70 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Males and females, ≥ 18 to ≤ 70 years of age 2. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria. 3. Patient has all 3 of the following based on features active on the day of the visits: 1. hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria. 2. BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1. 3. In the opinion of the investigator and the central adjudicator, there is sufficient disea…

Interventions

Drug
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
Drug
Placebo
Placebo

Locations (82)

Sierra Pacific Arthritis and Rheumatology Centers
Fresno, California
California Research Institute
Huntington Park, California
University of California, San Diego
La Jolla, California
Clinical Research of West Florida, Inc
Clearwater, Florida
Clinical Research of West Florida, Inc.
Tampa, Florida
Emory University
Atlanta, Georgia