A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Launched by ZENAS BIOPHARMA (USA), LLC · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called obexelimab for patients with systemic lupus erythematosus (SLE), a condition where the immune system mistakenly attacks the body's own tissues. The goal is to find out if obexelimab is effective and safe for people living with SLE. Currently, the trial is recruiting participants who are between 18 and 70 years old, have been diagnosed with SLE for at least 24 weeks, and show signs of active disease. To be eligible, participants need to be on standard lupus treatments like corticosteroids or immunosuppressants.

If you join the trial, you will be closely monitored by healthcare professionals to see how the treatment affects your condition. It’s important to know that certain health issues may prevent you from participating, such as severe kidney problems or other active autoimmune diseases. This study aims to help improve treatment options for SLE, potentially benefiting many patients in the future.

Gender

ALL

Eligibility 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 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.