Status:
RECRUITING
Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Primary Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- 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 subjects of childbearing potential must not become pregnant and so must be sexually inactive by abstinence or use contraceptive methods with a failure rate of \< 1%.
- Therefore, these women must have a negative serum pregnancy test at screening, and confirmed monthly while in study (with serum or Urine test), out to at least 12 months (taking account of the longest half-life which is that of 29.7 days and according to smPC) post last dose and agree to 1 of the following:
- 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 preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) OR
- 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 to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records
- 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 consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.
- 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
Exclusion
- 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 assessments or compromise subject safety
- 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
Key Trial Info
Start Date :
November 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 14 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05338190
Start Date
November 14 2022
End Date
November 14 2027
Last Update
September 11 2023
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 9400