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Tests treatment safety and results for Primary Immune Thrombocytopenia (ITP)
Official title Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT05338190
What this study is testing
What is Combination of Rituximab with subcutaneous belimumab?
Combination of Rituximab with subcutaneous belimumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for primary immune thrombocytopenia (itp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production. There are approximately 4,000 newly diagnosed ITP cases each year in France.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Primary ITP defined according to the standard definition criteria (Rodeghiero, Blood 2008)
- Previous response to corticosteroids and/or IgIV defined by a rise of platelet levels \> 30 x 109/L with at least a twofold increase from baseline...
- Platelet count ≤ 30 x 109/L within the previous month or \<50 x 109/L if presence of haemorrhagic events or other reason left up to investigator...
- ITP duration of more than 2 months but less than 5 years from diagnosis.
You likely can't join if
- Splenectomy
- Previous treatment with rituximab or any B-cell targeted therapy
- Common variable immunodeficiency
- Previous treatment with cyclophosphamide or ciclosporin
- Inclusion in another clinical trial less than 3 months before inclusion
- Previous anaphylactic shock to previous biologic therapy
See the full eligibility criteria
- Age ≥ 18 years
- Primary ITP defined according to the standard definition criteria (Rodeghiero, Blood 2008)
- Previous response to corticosteroids and/or IgIV defined by a rise of platelet levels \> 30 x 109/L with at least a twofold increase from baseline levels followed by a relapse.
- Platelet count ≤ 30 x 109/L within the previous month or \<50 x 109/L if presence of haemorrhagic events or other reason left up to investigator discretion.
- ITP duration of more than 2 months but less than 5 years from diagnosis.
- Normal bone marrow smear for patients above 60 years of age
- Negative pregnancy test results and effective contraception for women of childbearing age Female people of childbearing potential must not become pregnant and so must be sexually inactive by abstinence or use...
- Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the...
- Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 16 weeks after the last dose of study agent
- Oral contraceptive, either combined or progestogen alone
- Injectable progestogen
- Implants of levonorgestrel or etonogestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with \<1% failure rate as stated in the product label
- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers...
- Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) These allowed methods of contraception are only effective when used...
- Complete Vaccinal scheme against SARS-CoV2 according to the recommendations of the health authorities
- Gammaglobulin level ≥ 7 g/L
- Informed consent
- Affiliated to, or beneficiary of, a social security regime or similar
- Splenectomy
- Previous treatment with rituximab or any B-cell targeted therapy
- Common variable immunodeficiency
- Previous treatment with cyclophosphamide or ciclosporin
- Inclusion in another clinical trial less than 3 months before inclusion
- Previous anaphylactic shock to previous biologic therapy
- Chronic or ongoing severe infection requiring treatment or hospitalization in the 60 days preceding inclusion.
- Use of parenteral antibiotics within 60 days, current use of suppressive therapy for chronic infection such as tuberculosis, pneumocystis, cytomegalovirus, HSZ, herpes zoster, and atypical mycobacteria
- Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
- Psychiatric Illness impairing judgement.
- Neutrophils count \< 1,000/mm3 at inclusion
- Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen or core antibody (HbsAg or HBcAb)
- Impaired renal function as indicated by a serum creatinine level \> 2 mg/dl
- Liver function: AST (SGOT) and ALT (SGPT) ≥5xULN Total bilirubin ≥3 x ULN
- New York Heart Classification III or IV heart disease
- Previous history of malignancy in the last 5 years other than cutaneous carcinoma
- Previous history of Progressive multifocal leukoencephalopathy
- Previous history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.
- Alcohol or drug abuse or dependence, either current or within 1year
- Pregnant or breast-feeding woman
- Live, attenuated vaccinations must be administered at least 30 days before inclusion in study
- History of significant medical illness or clinically significant laboratory abnormality (or planned surgical procedure) which in the opinion of the investigator would interfere with the study procedures and / or...
- Body mass index \> 40
- PCR-confirmed SARS-CoV-2 infection
- Vulnerable persons, under the protection of justice,
- Persons deprived of their liberty by judicial or administrative decision,
- Persons admitted to a health or social establishment for purposes other than research,
- Persons under legal protection (guardianship, curatorship),
- Persons unable to express their consent
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.