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Safety and Efficacy of BMS-986528 with Tocilizumab in Patients with Refractory Rheumatoid Arthritis: A Phase 1/2a Open‑Label Study

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 looks at people with refractory rheumatoid arthritis, a type of arthritis that does not improve with usual medicines and causes joint pain, swelling, and stiffness. The investigational medicine being tested is called BMS-986528, which will be given as a subcutaneous injection, and participants may also continue receiving the approved drug tocilizumab by intravenous infusion as part of their regular care. The main purpose of the trial is to determine whether BMS-986528 can be used safely in this patient group.

After enrollment, participants will receive a series of injections of BMS-986528 over several weeks or months, with regular clinic visits for physical examinations and blood draws. The schedule includes an initial screening, a baseline visit, and follow‑up visits where doctors check for any side effects and collect blood samples to see how the drug moves through the body. The study is open‑label, meaning both the researchers and participants know which treatment is being given.

Safety will be assessed by counting any mild or serious side effects that occur during the study. Blood tests will also look at the amount of the drug present, changes in certain immune cells, levels of proteins called immunoglobulins, and whether the body creates its own antibodies against the drug. In addition, the effect on arthritis symptoms will be measured after about three months using a scoring system called DAS28-CRP, which combines joint swelling, pain, and a blood marker of inflammation to give an overall picture of disease activity.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and baseline assessments

    You attend the first study visit after joining the trial. during this visit a health professional records your medical history, performs a physical exam, and measures the activity of your rheumatoid arthritis using a score called das28‑crp.

    Blood samples are taken to check your overall health, to measure the number of b cells, and to establish baseline levels of immunoglobulins, which are proteins that help the immune system.

  2. Step 2

    First administration of bms‑986528

    On the same day or shortly after the baseline visit you receive the study drug bms‑986528 as a subcutaneous injection (a shot under the skin). the exact dose and how often it will be given are set by the study protocol.

    If you are already receiving tocilizumab as part of your usual care, the intravenous infusion of that medication continues according to its normal schedule.

  3. Step 3

    Regular safety monitoring and blood sampling

    You return to the study site at the intervals defined by the protocol (for example weekly or every few weeks). each visit includes a brief physical check, a review of any side effects, and additional blood draws.

    The blood samples are used to measure how much bms‑986528 is in your bloodstream, to track how quickly your body clears the drug, and to observe changes in b‑cell numbers, immunoglobulin levels, and the presence of any antibodies that your body might make against the study drug.

  4. Step 4

    Efficacy assessment at three months

    Approximately three months after the first injection, a detailed assessment of your rheumatoid arthritis symptoms is performed using the das28‑crp score. this helps determine whether bms‑986528 is having a beneficial effect on pain, swelling, and inflammation.

  5. Step 5

    Continuation of treatment and final evaluation

    You continue to receive bms‑986528 injections and any ongoing tocilizumab infusions for the remainder of the study period as defined by the protocol.

    At the end of the trial a final visit is scheduled. during this visit safety is reviewed one last time, blood samples are collected for the same laboratory measurements, and the overall effect of the treatment on your rheumatoid arthritis is summarized.

Who can join the trial?

5 criteria

  • Be an adult between 18 and 65 years old.
  • Have a diagnosis of rheumatoid arthritis (a long‑lasting joint disease that causes pain and swelling).
  • Your rheumatoid arthritis must be classified as difficult‑to‑treat (meaning it has not responded well to the usual medicines) according to international guidelines.
  • Have had rheumatoid arthritis for more than 2 years.
  • Both men and women are allowed to join the study.

Who cannot join the trial?

3 criteria

  • Having juvenile arthritis (a type of arthritis that starts before age 18) or any inflammatory arthritis that began before you turned 18. Inflammatory arthritis means joint swelling and pain caused by inflammation.
  • Having a form of rheumatoid arthritis called seronegative rheumatoid arthritis when doctors are not sure you really have rheumatoid arthritis. Seronegative means the usual blood test markers for rheumatoid arthritis are not present.
  • Having symptoms that could make it difficult for researchers to accurately check your joints, such as if you have fibromyalgia. Fibromyalgia is a condition that causes widespread muscle pain and tenderness, which can interfere with joint assessments.
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Investigated drugs

  • BMS-986528

    is the experimental drug being studied in this trial. It is given as a small amount injected under the skin (subcutaneous injection) in a liquid form. The purpose of using BMS-986528 is to see if it is safe for people with rheumatoid arthritis that has not responded to other treatments, and to learn how the body absorbs and uses the drug, as well as whether it helps reduce arthritis symptoms.

  • Tocilizumab

    is a medication that participants may already be taking as part of their regular rheumatoid arthritis care. It is given through a vein (intravenous infusion). In this study, Tocilizumab is used as background therapy, meaning it continues to treat the arthritis while the new drug is being tested, allowing researchers to see how the new drug works in combination with standard treatment.

What is already known about the treatment

  • BMS-986528

    This investigational drug is given as a subcutaneous injection in a clear solution for injection. It is currently being studied and is not yet approved for any medical use. The main aim is to treat people with rheumatoid arthritis that does not respond to other medicines. It works by blocking a protein called angiopoietin‑2, which helps reduce inflammation and abnormal blood‑vessel growth, and it belongs to the class of monoclonal antibodies that target angiogenesis.

  • Tocilizumab

    This approved medication is administered by intravenous infusion, usually in a hospital or clinic setting. It is widely used for rheumatoid arthritis and other inflammatory conditions. Tocilizumab blocks the interleukin‑6 (IL‑6) receptor, which lowers the body’s inflammatory response, and it is classified as an IL‑6 receptor antagonist monoclonal antibody.

Investigated diseases

Refractory rheumatoid arthritis - Rheumatoid arthritis is a chronic autoimmune condition that causes inflammation of the joints. It often begins with stiffness and swelling in the hands and feet and can spread to other joints over time. The inflammation leads to pain, reduced movement, and gradual damage to cartilage and bone. In refractory or difficult‑to‑treat cases, symptoms persist and joint damage continues despite usual medicines. The disease may also cause fatigue and a general feeling of being unwell as it progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-520666-22-00Protocol codeIM0620001Estimated enrolment72 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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