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A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Active Not RecruitingPhase 2

Sponsor: Zenas BioPharma (USA), LLC

Conditions: Systemic Lupus Erythematosus

Interventions: Obexelimab, Placebo

Countries: United States, Belgium, Bulgaria, Canada, China, Denmark, Germany, Greece

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (110)

Peoria, Arizona, United States
Fresno, California, United States
Huntington Park, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Tustin, California, United States
New Haven, Connecticut, United States
Clearwater, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
Willowbrook, Illinois, United States
Lake Charles, Louisiana, United States
Baltimore, Maryland, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
Sterling Heights, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Fayetteville, North Carolina, United States
Salisbury, North Carolina, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Houston, Texas, United States
Houston, Texas, United States
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