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Monoclonal Antibodies

Obexelimab for Lupus (SunStone Trial)

Phase 2
Recruiting
Research Sponsored by Zenas BioPharma (USA), LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1
Patient has BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1
Must not have
Active lupus nephritis for which current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial aims to test how well obexelimab works and how safe it is for people with systemic lupus erythematosus (SLE).

Who is the study for?
This trial is for men and women aged 18 to 70 with systemic lupus erythematosus (SLE). They must have active disease symptoms, be on standard SLE treatments like steroids or antimalarials, and meet specific criteria for disease severity. People can't join if they don't meet the required level of disease activity or fall outside the age range.
What is being tested?
The study is testing Obexelimab's effectiveness and safety in treating SLE compared to a placebo. Participants will either receive Obexelimab or a placebo without knowing which one, to measure true effects of the drug versus no active treatment.
What are the potential side effects?
While not specified here, side effects from drugs like Obexelimab could include allergic reactions, infusion-related discomforts, infections due to immune system suppression, nausea, headaches, and potential unknown risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lupus symptoms are moderately severe.
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My lupus is active, affecting at least one organ system.
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I am between 18 and 70 years old.
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I am currently on treatment for lupus with steroids, antimalarials, or immunosuppressants.
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I was diagnosed with lupus more than 24 weeks ago and meet specific lupus criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My current medications for lupus nephritis are not effective.
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I have had a blood clot in the past 6 months, or in the past year due to a specific clotting disorder.
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I have severe brain or mental health issues due to lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure
Secondary study objectives
Measures
Other study objectives
Additional Outcome Measures

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ObexelimabExperimental Treatment1 Intervention
Obexelimab will be administered as a subcutaneous injection for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered as a subcutaneous injection for 24 weeks.

Find a Location

Who is running the clinical trial?

Zenas BioPharma (USA), LLCLead Sponsor
7 Previous Clinical Trials
580 Total Patients Enrolled
~127 spots leftby Nov 2025
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