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Study of Obexelimab Treatment for Adults with Systemic Lupus Erythematosus (SLE)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying a treatment for Systemic Lupus Erythematosus, an autoimmune disease where the body's immune system attacks its own tissues. The study will test a new medication called obexelimab to determine if it can reduce disease activity in people with this condition. The medication will be given through subcutaneous injection, which means it is injected under the skin.

The main purpose of this research is to evaluate how well obexelimab works compared to placebo in reducing lupus disease activity. During the study, participants will also receive standard lupus treatments, which may include antimalarial medications, corticosteroids like prednisolone, or other medications that suppress the immune system.

The study will last 24 weeks, during which participants will receive either obexelimab or placebo injections. Throughout the study, doctors will monitor various aspects of the disease, including skin symptoms, joint problems, and overall disease activity. They will also track how the treatment affects participants' fatigue levels and general well-being. The maximum daily dose of obexelimab will be 250 mg, with a total maximum dose of 6000 mg over the course of treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated if you are between 18 and 70 years old and have been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 24 weeks

    Blood tests will be performed to check for specific antibodies related to lupus

    Your current disease activity will be assessed using specific medical scoring systems

  2. Step 2

    Treatment period start

    You will be randomly assigned to receive either obexelimab or a placebo through subcutaneous injection (injection under the skin)

    You will continue your current lupus medications, which may include:

    - Oral corticosteroids (maximum 20 mg per day)

    - Antimalarial medications at stable doses

    - One immunosuppressant medication at a stable dose

  3. Step 3

    Regular assessments

    Your lupus disease activity will be monitored throughout the 24-week study period

    Regular evaluations will track changes in:

    - Skin symptoms

    - Joint problems

    - Fatigue levels

    - Overall disease activity

  4. Step 4

    Final evaluation

    At week 24, a final assessment will determine the effectiveness of the treatment

    The evaluation will include:

    - Overall disease activity measurement

    - Assessment of lupus symptoms

    - Review of any changes in your regular medication doses

Who can join the trial?

16 criteria

  • Age between 18 and 70 years
  • Must be able to provide signed informed consent and follow study requirements
  • Must have been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 24 weeks before screening
  • Must have at least one of these test results during screening:
    • Positive ANA test (a blood test that looks for antibodies) at level 1:80 or higher
    • Positive anti-dsDNA (a specific antibody test)
    • Positive anti-Sm (another specific antibody test)
    • Must be currently taking at least one of these medications:
      • Oral corticosteroids (at stable dose of 20 mg or less per day)
      • Antimalarial medications (at stable dose for at least 8 weeks)
      • Immunosuppressant medications (at stable dose for at least 8 weeks)
      • Must have active disease symptoms meeting specific measurement criteria on medical assessment scales
      • For women who can become pregnant:
        • Must not be pregnant or breastfeeding
        • Must agree to use approved birth control methods
        • Must have negative pregnancy tests before starting the study
        • Must agree not to donate eggs during the study and for 8 weeks after
        • For men:
          • Must agree to use approved birth control methods or be surgically sterile
          • Must agree not to donate sperm during the study and for 8 weeks after

Who cannot join the trial?

15 criteria

  • Previous severe allergic reactions to any medications or biologics (medicines derived from living organisms)
  • Active or chronic infections, including hepatitis B, hepatitis C, HIV, or tuberculosis
  • Severe kidney disease requiring dialysis (blood filtering treatment)
  • Severe liver disease or abnormal liver function tests
  • History of cancer within the past 5 years (except treated non-melanoma skin cancer)
  • Pregnant or breastfeeding women
  • Use of other investigational drugs within 30 days before starting the study
  • Major surgery planned during the study period
  • Unstable heart conditions or recent heart problems
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Current substance abuse or alcohol dependency
  • Mental health conditions that could interfere with study participation
  • Unable to follow study procedures or attend scheduled visits
  • Taking medications that could interact with the study drug
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Investigated drugs

Obexelimab is an investigational medication being studied for treating systemic lupus erythematosus (SLE), an autoimmune disease where the body's immune system attacks its own tissues. This medication works by targeting specific immune cells to help reduce inflammation and disease activity in patients with lupus. It is administered to patients alongside their standard lupus treatments to evaluate if it can better control lupus symptoms and reduce disease flares.

What is already known about the treatment

Obexelimab – An investigational monoclonal antibody medication that is currently being studied in clinical trials for the treatment of Systemic Lupus Erythematosus (SLE), an autoimmune disease. The drug is administered through intravenous infusion and works by targeting and binding to specific immune system proteins involved in the abnormal immune response characteristic of lupus. This biological agent belongs to the class of immunomodulatory drugs, designed to modify the immune system's activity to reduce inflammation and disease symptoms in patients with SLE. The medication is still in Phase 2 clinical trials to evaluate its safety and effectiveness, and it is not yet approved for general medical use.

Investigated diseases

Systemic Lupus Erythematosus - A chronic autoimmune disease where the body's immune system mistakenly attacks its own tissues and organs. The condition can affect multiple body systems, including joints, skin, kidneys, blood cells, brain, heart, and lungs. Symptoms often develop slowly and can vary from mild to severe, with periods of flares when symptoms worsen and remissions when symptoms improve. Common symptoms include joint pain, skin rashes (particularly a butterfly-shaped rash across the face), fatigue, and fever. The disease typically follows an unpredictable pattern of remissions and relapses throughout a person's life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510584-37-00Protocol codeZB012-02-001Estimated enrolment202 patientsSponsorZenas Biopharma (USA) LLC

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