Status:
RECRUITING
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Zenas BioPharma (USA), LLC
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
Detailed 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...
Eligibility Criteria
Inclusion
- Males and females, ≥ 18 to ≤ 70 years of age
- Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
- Patient has all 3 of the following based on features active on the day of the visits:
- hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.
- BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
- 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.
- 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
- 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.
- 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.
- 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.
- Active severe neuropsychiatric or central nervous system SLE.
- 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.
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06559163
Start Date
September 17 2024
End Date
September 1 2026
Last Update
July 30 2025
Active Locations (82)
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1
Sierra Pacific Arthritis and Rheumatology Centers
Fresno, California, United States, 93710
2
California Research Institute
Huntington Park, California, United States, 90255
3
University of California, San Diego
La Jolla, California, United States, 92037
4
Clinical Research of West Florida, Inc
Clearwater, Florida, United States, 33765