NCT06559163 · Zenas BioPharma (USA), LLC
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
(SunStone)
What this study is about
This study aims to examine the effectiveness and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
View original scientific description
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
Interventions
DRUG
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
DRUG
Placebo
Placebo
Primary outcome measures
Primary Outcome Measure
Time frame: 24 weeks
Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current med
Where
- Fresno, California
- Huntington Park, California
- La Jolla, California
- Clearwater, Florida
- Tampa, Florida
- Atlanta, Georgia
- Lake Charles, Louisiana
- Detroit, Michigan
- Lansing, Michigan
- Charlotte, North Carolina
- Oklahoma City, Oklahoma
- Hershey, Pennsylvania
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2025 · Source of record for eligibility and locations