Actively Recruiting
A Phase 3 Randomized, Double-blind Trial Comparing Subcutaneous Belimumab or Placebo Added to Rituximab in Adults With Persistent or Chronic Immune Thrombocytopenia
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-09-11
132
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Primary immune thrombocytopenia (ITP) is an autoimmune disorder where the body's immune system attacks its own platelets, leading to low platelet counts and increased bleeding risk. This trial focuses on adults with persistent or chronic ITP who have not had lasting success with standard therapies. Researchers are comparing the effects of combining the drug rituximab with either subcutaneous belimumab or a placebo to see which treatment better improves platelet counts and reduces disease activity over one year. Participants are randomly assigned to one of two groups. One group receives weekly injections of belimumab under the skin for 24 weeks alongside two intravenous doses of rituximab, given one and three weeks after starting treatment. The other group receives placebo injections on the same schedule with the same rituximab dosing. This double-blind study is conducted at multiple international centers and aims to determine if adding belimumab provides better outcomes than rituximab alone. During the study, participants will have regular blood tests to monitor platelet levels, immune cell populations, antibody levels, and signs of infections or low immunoglobulin levels at specific weeks up to two years. Researchers will assess overall response rates at one year and track safety measures, including infections and immune system changes. The total participation time includes treatment and extended follow-up to evaluate both effectiveness and safety over time.
CONDITIONS
Brief Title
Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with primary immune thrombocytopenia (ITP) as per standard criteria
- Previous response to corticosteroids and/or intravenous immunoglobulin with platelet increase followed by relapse
- Platelet count 30 x 10⁹/L or less within the last month, or less than 50 x 10⁹/L if bleeding or other reasons
- ITP duration between 2 months and 5 years from diagnosis
- Normal bone marrow smear if older than 60 years
- Negative pregnancy test and effective contraception for women of childbearing potential
- Completed COVID-19 vaccination as recommended
- Gammaglobulin level 7 g/L or higher
- Provided informed consent
- Affiliated with social security or similar
You will not qualify if you...
- History of splenectomy
- Prior treatment with rituximab or B-cell targeted therapies
- Common variable immunodeficiency
- Previous treatment with cyclophosphamide or ciclosporin
- Participation in another clinical trial within 3 months
- History of anaphylactic shock to biologic therapies
- Recent severe infection or ongoing infection requiring hospitalization or treatment
- Use of certain antibiotics or suppressive therapies for chronic infections
- High suicide risk or psychiatric illness impairing judgment
- Neutrophil count below 1,000/mm³
- Positive tests for HIV, hepatitis B or C
- Impaired kidney or liver function above specified thresholds
- Severe heart disease (New York Heart Class III or IV)
- History of cancer in last 5 years except skin carcinoma
- History of progressive multifocal leukoencephalopathy
- History of major organ or stem cell transplant
- Alcohol or drug abuse within the past year
- Pregnant or breastfeeding women
- Recent live attenuated vaccination within 30 days
- Significant medical illness or lab abnormalities that interfere with study
- Body mass index over 40
- Confirmed COVID-19 infection
- Vulnerable persons under legal protection or deprived of liberty
- Unable to provide informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive weekly subcutaneous injections of belimumab or placebo for 24 weeks combined with intravenous Rituximab given twice during the first 21 days.
Weekly visits for up to 24 weeks
Duration - Up to 80 weeks after treatment
Participants are monitored for safety and treatment response up to Week 104 after treatment ends.
Visits at Week 36, Week 52, Week 88, and Week 104
Trial Site Locations
Total: 1 location
1
Henri Mondor Hospital
Créteil, France, 9400
Actively Recruiting
Research Team
M
Matthieu MAHEVAS, Professor of medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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