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Clinical Trials in Poland / NCT06559163
Active, not recruiting Phase 2

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

NCT06559163 · tracked via the Priya Life Science Poland tracker
Phase
Phase 2
Started
2024-09-17
Last updated
2026-08-18

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

Obexelimab →Placebo

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

Placebo: Placebo

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 disease activity to warrant enrollment into a clinical study with an investigational agent. 4. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant. Exclusion Criteria: 1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed. 2. A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state. 3. Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis. 4. Active severe neuropsychiatric or central nervous system SLE. 5. Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.

Primary outcome measure(s)

Trial sites (110)

FacilityCityRegionStatus
Onyx Clinical Research Peoria Arizona
Sierra Pacific Arthritis and Rheumatology Centers Fresno California
California Research Institute Huntington Park California
University of California, San Diego La Jolla California
University of California, Los Angeles Los Angeles California
Solace Clinical Research Tustin California
Yale University New Haven Connecticut
Clinical Research of West Florida, Inc Clearwater Florida
Clinical Research of West Florida, Inc. Tampa Florida
Emory University Atlanta Georgia
AARA Clinical Research - Chicago Arthritis & Regenerative Medicine Chicago Illinois
Orthoillinois Rockford Illinois
Willow Rheumatology and Wellness Willowbrook Illinois
Accurate Clinical Research Lake Charles Louisiana
Axon Clinical Research Baltimore Maryland
UMass Chan Medical School Worcester Massachusetts
Henry Ford Hospital Detroit Michigan
Juno DO, PC Lansing Michigan
Revive Research Institute - Sterling Heights Sterling Heights Michigan
Velocity Clinical Research St Louis Missouri
Hospital for Special Surgery New York New York
SUNY Upstate Medical University Syracuse New York
DJL Clinical Research PLLC Charlotte North Carolina
Cross Creek Medical Clinic Fayetteville North Carolina
Onsite Clinical Solutions Salisbury North Carolina
Oklahoma Medical Research Foundation Oklahoma City Oklahoma
Penn State - Hershey Medical Center Hershey Pennsylvania
AARA Clinical Research - Rheumatology Specialty Center Willow Grove Pennsylvania
Prolato Clinical Research Center (PCRC) Houston Texas
Accurate Clinical Research Houston Texas
Prime Clinical Research - Lewisville Lewisville Texas
Prime Clinical Research - Mansfield Mansfield Texas
UZ Leuven Leuven Belgium
CHU de Liege Liège Belgium
Medical Center Medtech Services EOOD Haskovo Bulgaria
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv" Plovdiv Bulgaria
Diagnostic Consultative Center Convex EOOD Sofia Bulgaria
Richmond Clinical Trials Richmond British Columbia
Riverside Professional Centre Sydney Nova Scotia
Anhui Provincial Hospital (The First Affiliated Hospital of USTC) Hefei Anhui

+ 70 more sites — see the full list on the official registry below.

More Zenas BioPharma (USA), LLC trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06559163 on ClinicalTrials.gov ↗ ← All trials in Poland