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Not yet recruitingRare disease

Safety, Tolerability and Dose Finding of RO7871996 and Obinutuzumab in Patients with Active Systemic Lupus Erythematosus

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on people with active Systemic Lupus Erythematosus, a condition in which the immune system mistakenly attacks the body’s own tissues, causing pain, skin rash, fatigue, and possible damage to organs. The investigational medicine being examined is called RO7871996, which will be administered as a solution injected subcutaneous (under the skin). The drug will be tested on its own and compared with a placebo.

The purpose of the trial is to find out whether the medicine is safe, tolerable, and able to improve disease symptoms. Participants will first receive a single low dose; if this is well‑tolerated, they may receive higher single doses or several doses over a few weeks. Throughout the study, regular visits will be scheduled to check for side effects, review laboratory test results, and monitor heart rhythm. A small group will receive a placebo so that any changes can be compared, and follow‑up will continue after the last dose to gather information on how the drug behaves in the body and its effect on the disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    You will undergo a series of tests to record your current health status, including blood work, vital‑sign measurements, and an electrocardiogram (ECG).

    These assessments create a reference point for evaluating any changes that occur after you receive the study medication.

  2. Step 2

    First Subcutaneous Injection of RO7871996

    You will receive the investigational drug RO7871996 by a subcutaneous (under‑the‑skin) injection.

    The exact dose and volume will be determined by the study protocol and may vary depending on the dose‑escalation level you are assigned to.

    This is the first administration of the drug in a human study, so careful monitoring will follow.

  3. Step 3

    Safety Monitoring After First Dose

    After the injection, you will be observed for a period of time to detect any immediate reactions.

    You will return for scheduled visits during which the study team will check for dose‑limiting adverse events, record any side effects, and repeat laboratory tests and vital‑sign measurements.

  4. Step 4

    Additional Doses in Multiple Ascending Dose Cohort

    If you are placed in a cohort that receives multiple doses, you will be given further subcutaneous injections of RO7871996 according to the study schedule.

    Each subsequent dose may be higher than the previous one, following the dose‑escalation design of the trial.

    Between doses, you will continue to attend clinic visits for safety checks, blood sampling to study pharmacokinetics (how the drug moves through your body), and assessments of pharmacodynamics (how the drug affects your disease).

  5. Step 5

    Comparator IV Infusion of Obinutuzumab (Gazyvaro)

    In some parts of the study, you may receive the comparator medication obinutuzumab, which is administered as an IV infusion (the drug is delivered slowly through a vein).

    The dose and frequency of this infusion are defined by the trial protocol and will be explained to you before administration.

    This treatment allows the study to compare the effects of RO7871996 with an existing therapy.

  6. Step 6

    Ongoing Assessments of Efficacy and Safety

    Throughout the trial, you will have regular visits where the study team will evaluate the efficacy of the medication, meaning how well it helps control your active systemic lupus erythematosus (SLE).

    Safety will continue to be monitored by recording any adverse events, checking laboratory results, and measuring vital signs and ECG parameters.

    The study may last for several months, and the overall trial period is projected to run from December 2026 to September 2030.

  7. Step 7

    Final Study Visit and Completion

    At the end of your participation, you will attend a final visit that includes a comprehensive health assessment, final laboratory tests, and a discussion of the overall study findings.

    After this visit, your involvement in the trial is considered complete.

Who can join the trial?

7 criteria

  • Have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks (about 6 months) before signing the consent, using the 2019 EULAR/ACR classification criteria (a set of guidelines doctors use to be sure the disease is present).
  • Show at least one of the following SLE‑related autoantibodies (blood proteins that mistakenly target the body) within the past 5 years or at the screening visit: a positive antinuclear antibody (ANA) test with a titer of 1:160 or higher, or an elevated anti‑double‑stranded DNA (anti‑dsDNA) level above the normal upper limit, or an elevated anti‑Smith (anti‑Sm) level above the normal upper limit.
  • Be currently taking oral glucocorticoids (steroid medication such as prednisone) at a dose of 20 mg per day or less, and the dose must have been unchanged for at least 7 days before the first study day.
  • Be currently taking at least one conventional immunosuppressant (such as azathioprine, sulfasalazine, mycophenolate mofetil, mycophenolic acid, a calcineurin inhibitor, or methotrexate) and the dose must have been stable for at least 6 weeks before the first study day and expected to stay stable during the study.
  • Both men and women are eligible to participate.
  • People who are considered a vulnerable population (for example, children or individuals who may need extra protection) may be included.
  • Participants must be in the age ranges that include children and adults (generally age 12 years and older).

Who cannot join the trial?

2 criteria

  • Severe active systemic autoimmune disease other than SLE – a serious condition where the immune system attacks many parts of the body (other than lupus) and is currently causing symptoms, which would keep you from joining the study.
  • High risk for clinically significant bleeding – a chance of serious bleeding that could affect your health, making participation unsafe.
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Investigated drugs

  • RO7871996

    is an experimental medicine being tested for the first time in people with active systemic lupus erythematosus (SLE). It is given as a small amount injected under the skin (subcutaneous injection) in a liquid form. The study is looking at how safe it is, how well the body handles it, and whether it can improve the symptoms of lupus when given once or repeatedly over time.

  • Gazyvaro

    is a treatment that contains the active substance obinutuzumab. It is given through an IV infusion, which means it is slowly delivered into a vein using a drip. In this trial, Gazyvaro is used as a comparator to help researchers understand how the new experimental drug (RO7871996) works compared to an existing therapy for lupus. It helps assess the effectiveness and safety of both treatments in participants.

What is already known about the treatment

  • RO7871996

    This investigational drug is supplied as a sterile solution for subcutaneous injection, allowing it to be given under the skin as a simple injection. It is currently in early clinical development, with Phase 1/2 studies evaluating its safety and effectiveness in patients with active systemic lupus erythematosus. The medication is designed to modulate the immune system by binding to a specific protein that helps control inflammatory signaling, thereby reducing disease activity. It belongs to the class of experimental biologic agents known as monoclonal antibodies targeting immune pathways.

  • Gazyvaro

    Gazyvaro is provided as a concentrate for solution for infusion, which is diluted and delivered by intravenous infusion into a vein. It is an approved medicine that has been authorized for the treatment of certain blood cancers, such as chronic lymphocytic leukemia and follicular lymphoma. The drug works by attaching to the CD20 protein on B‑cells, marking them for destruction and thus lowering the number of cells that drive the disease. It is classified as a CD20‑directed monoclonal antibody used in oncology and is being studied as a comparator treatment in lupus trials.

Investigated diseases

Systemic lupus erythematosus - Systemic lupus erythematosus is an autoimmune condition in which the body’s immune system mistakenly attacks its own tissues. It can involve the skin, joints, kidneys, heart, lungs, and brain, producing a range of symptoms such as rash, joint swelling, and fatigue. The disease often follows a pattern of flares, when symptoms worsen, followed by periods of relative calm. Repeated flares may lead to gradual organ damage over months or years. The course of the illness varies widely between individuals.
Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2026-527221-35-00Protocol codeBP46776Estimated enrolment70 patientsSponsorF. Hoffmann-La Roche AG

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