A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Summary

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

Eligibility

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.

Conditions2

Locations16 sites

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