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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Centre Hospitalier Victor Dupouy Argenteuil France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Alexandra Lepeve Dunkirk France
Centre Hospitalier Saint Nazaire St Nazaire France
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Htpytkrp Ugaxiabcywfzai Sulnimovnx &afdlow Hioixjk dw Hnusryfggra STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
14.11.2022

Trial locations

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.

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 ID:
2024-516168-27-00
Protocol code:
APHP201098
NCT ID:
NCT05338190
Trial Phase:
Therapeutic confirmatory (Phase III)

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