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Testing obexelimab for treating systemic lupus erythematosus

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

Phase 2 Interventional Zenas BioPharma (USA), LLC · NCT06559163

This study is testing a new medication called obexelimab to see if it can help people with active systemic lupus erythematosus feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment190 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorZenas BioPharma (USA), LLC Industry-sponsored
Drugs / interventionsobexelimab
Locations82 sites (Fresno, California and 81 other locations)
Trial IDNCT06559163 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of obexelimab in patients diagnosed with systemic lupus erythematosus (SLE). Participants will undergo a 24-week treatment period with either obexelimab or a placebo, followed by a 12-week follow-up. Eligible patients must have active SLE and meet specific clinical criteria, including a certain level of disease activity. Throughout the study, patients will have regular assessments to monitor their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of systemic lupus erythematosus and active disease.

Not a fit: Patients with active lupus nephritis or those not meeting the study's disease activity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise with similar investigational approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fresno, California and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusSLELupus
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.