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Study of rituximab and belimumab combination compared to rituximab alone in adults with persistent or chronic immune thrombocytopenia (ITP)

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What is this trial about?

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

This study focuses on adults with immune thrombocytopenia (ITP), a condition where the immune system mistakenly attacks and destroys blood platelets, leading to increased risk of bleeding. The research evaluates a combination treatment using two medications: rituximab and belimumab.

The purpose of this research is to determine if combining rituximab with weekly injections of belimumab works better than rituximab with placebo in treating persistent or chronic immune thrombocytopenia. The study will last for 104 weeks (2 years), during which patients will receive either belimumab or placebo injections for 24 weeks, along with two doses of rituximab given early in the treatment period.

Throughout the study, researchers will monitor platelet levels, immune system components, and overall health status. The treatment involves subcutaneous (under the skin) injections of belimumab or placebo, while rituximab is given through intravenous administration. Patients will have regular check-ups to monitor their response to treatment and any potential side effects.

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 evaluation and treatment start

    Your participation begins with an initial evaluation to confirm platelet count and other health parameters

    You will be randomly assigned to one of two treatment groups: Group A (belimumab) or Group B (placebo)

    On Day 7, you will receive your first dose of rituximab (1,000 mg) through intravenous infusion

    On Day 21, you will receive your second dose of rituximab (1,000 mg)

  2. Step 2

    Weekly treatment period

    For 24 weeks, you will receive weekly injections under the skin

    Depending on your group assignment, these injections will contain either belimumab 200 mg or placebo

    Regular blood tests will monitor your platelet levels and immune system

  3. Step 3

    Follow-up evaluations

    Your health will be monitored at specific time points: weeks 6, 12, 24, 36, 52, 78, and 104

    Each visit includes blood tests to check platelet counts and immune system function

    At weeks 12, 24, and 52, you will complete quality of life questionnaires

    Any bleeding events will be evaluated during these visits

    The study continues until week 104 (approximately 2 years) with regular monitoring

  4. Step 4

    Health monitoring

    Throughout the study, your blood protein levels will be regularly checked

    Any infections requiring hospitalization will be documented

    Your platelet count will be monitored at each visit

    The medical team will assess your overall health status and any side effects

Who can join the trial?

11 criteria

  • Must be 18 years or older
  • Must provide informed consent to participate in the study
  • Must have social security coverage or similar insurance
  • Must have primary immune thrombocytopenia (ITP) - a condition where the immune system attacks blood platelets
  • Must have previously responded temporarily to corticosteroids (anti-inflammatory medications) or IgIV (immune system proteins given through IV) with platelet levels rising above 30 G/L, but then experienced a relapse
  • Must have current platelet count of 30 x 109/L or lower within the past month, or below 50 x 109/L if bleeding is present
  • Must have been diagnosed with ITP between 2 months and 10 years ago
  • If over 60 years old, must have normal bone marrow test results
  • For women who can become pregnant: must have negative pregnancy test and use reliable birth control (with less than 1% failure rate)
  • Must have completed full vaccination against COVID-19 as recommended by health authorities
  • Must have gammaglobulin level (type of protein in blood) of 7 g/L or higher

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years old
  • Previous unsuccessful treatment with rituximab (a type of antibody medication)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Pregnant or breastfeeding women
  • History of blood clotting disorders other than immune thrombocytopenia
  • Active cancer or history of cancer in the past 5 years
  • Major surgery within 8 weeks before starting the study
  • Participation in other clinical trials within 30 days before this study
  • Severe kidney disease (poor kidney function)
  • Severe liver disease (poor liver function)
  • Uncontrolled high blood pressure
  • History of severe allergic reactions to medications
  • Mental health conditions that could affect participation in the study
  • Use of prohibited medications within 4 weeks before the study start
  • Any condition that, in the investigator's opinion, makes participation unsafe
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Investigated drugs

Rituximab is a medication used to treat various autoimmune conditions and certain types of blood disorders. It works by targeting specific immune cells called B cells that may be involved in causing inflammation and immune system problems. In this trial, it is given through an intravenous infusion. Belimumab is a medication that helps control overactive immune systems by reducing the activity of certain proteins that contribute to autoimmune conditions. In this trial, it is given as an injection under the skin (subcutaneously) once per week. These medications are being tested together to see if their combination is more effective than using rituximab alone in treating immune thrombocytopenia (ITP), a condition where the immune system attacks blood platelets.

What is already known about the treatment

  • Rituximab

    A monoclonal antibody medication administered intravenously at a fixed dose of 1,000 mg, typically given in two doses on specific days. This medication belongs to the class of targeted immunotherapy drugs and works by binding to CD20 proteins found on B lymphocytes, effectively reducing their numbers in the body. It is primarily used in treating immune thrombocytopenia (ITP) and various autoimmune conditions by suppressing the immune response that attacks platelets. The medication has a well-established safety profile and is available as both original and biosimilar versions.

  • Belimumab

    A human monoclonal antibody medication administered subcutaneously on a weekly basis over a 24-week period. This medication targets and inhibits B-lymphocyte stimulator (BLS), a protein that plays a crucial role in the survival of B cells involved in autoimmune responses. It is being studied for use in immune thrombocytopenia (ITP) as a combination therapy with rituximab to enhance treatment effectiveness. The medication works by reducing abnormal immune system activity that leads to low platelet counts in ITP patients.

Investigated diseases

Immune Thrombocytopenia – A blood disorder where the immune system mistakenly attacks and destroys platelets, which are blood cells needed for normal blood clotting. In persistent and chronic forms, the condition lasts longer than 6 months and can continue for years. The reduced number of platelets in the blood makes it harder for blood to clot normally. The condition can develop gradually or suddenly, and it can affect both children and adults. The immune system produces antibodies that attach to platelets, leading to their destruction in the spleen or liver.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516168-27-00Protocol codeAPHP201098Estimated enrolment132 patientsSponsorAssistance Publique Hopitaux De Paris

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