A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT06559163

Run by

Zenas BioPharma (USA), LLC

People needed

190

Starts

2024-09-17

Expected to finish

2026-09-01

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• California Research Institute — Huntington Park, California, United States (enrolling)
• University of California, San Diego — La Jolla, California, United States (enrolling)
• Clinical Research of West Florida, Inc — Clearwater, Florida, United States (enrolling)
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Accurate Clinical Research — Lake Charles, Louisiana, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• June DO, PC — Lansing, Michigan, United States (enrolling)
• Juno DO, PC — Lansing, Michigan, United States (enrolling)
• DJL Clinical Research PLLC — Charlotte, North Carolina, United States (enrolling)
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (enrolling)
• Penn State - Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
• Prolato Clinical Research Center (PCRC) — Houston, Texas, United States (enrolling)
• Accurate Clinical Research — Houston, Texas, United States (enrolling)
• Prime Clinical Research - Mansfield — Mansfield, Texas, United States (enrolling)
• CHU de Liege — Liège, Belgium (enrolling)
• Medical Center Medtech Services EOOD — Haskovo, Bulgaria (enrolling)
• University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv" — Plovdiv, Bulgaria (enrolling)
• Richmond Clinical Trials — Richmond, British Columbia, Canada (enrolling)
• Riverside Professional Centre — Sydney, Nova Scotia, Canada (enrolling)
• Anhui Provincial Hospital (The First Affiliated Hospital of USTC) — Hefei, Anhui, China (enrolling)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Sierra Pacific Arthritis and Rheumatology Centers — Fresno, California, United States (enrolling)

Full record on ClinicalTrials.gov

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