A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Sierra Pacific Arthritis and Rheumatology Centers, Fresno, California, United States
• California Research Institute, Huntington Park, California, United States
• University of California, San Diego, La Jolla, California, United States
• Clinical Research of West Florida, Inc, Clearwater, Florida, United States
• Clinical Research of West Florida, Inc., Tampa, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Accurate Clinical Research, Lake Charles, Louisiana, United States
• Henry Ford Hospital, Detroit, Michigan, United States
• June DO, PC, Lansing, Michigan, United States
• Juno DO, PC, Lansing, Michigan, United States
• DJL Clinical Research PLLC, Charlotte, North Carolina, United States
• Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States

+ 70 more sites.

Who to contact

Patient and Medical Information · 833-269-4696 · clinicaltrialsinfo@zenasbio.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06559163.