Status:
COMPLETED
A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
Lead Sponsor:
Bioverativ, a Sanofi company
Conditions:
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: \- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: * To asses...
Detailed Description
Study duration: * Screening period: up to 56 days * Transition period between last sutimlimab dose and first dose of BIVV020 (for participants who were previously receiving sutimlimab): 14 days, incl...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Male and female participants ≥18 years of age at the time of signing the informed consent
- Confirmed diagnosis of primary ITP; for participants who previously received sutimlimab in study TDR16218 (NCT03275454), a response to sutimlimab must have been obtained, as defined by platelet count ≥30 × 10\^9/L on 2 visits at least 7 days apart
- For participants who have not previously received sutimlimab: persistent/chronic ITP (ITP lasting for ≥6 months) and all the following conditions:
- Platelet count ≤30 × 10\^9/L on 2 occasions at least 5 days apart during the Screening Period;
- Lack of an adequate platelet count response (as defined by maintenance of sustained platelet count ≥30 × 109/L in the absence of bleeding) to at least 2 ITP treatments, 1 of which was a thrombopoietin receptor agonist. Other ITP treatments include: IVIg, anti-D immunoglobulin, corticosteroids, splenectomy, rituximab, cyclophosphamide, azathioprine, danazol, cyclosporin A, mycophenolate mofetil, or fostamatinib.
- If receiving weekly thrombopoietin receptor agonist dosing, the last dose must have been administered ≥7 days before the first dose of BIVV020. If receiving daily thrombopoietin receptor agonist dosing, the last dose must have been administered ≥24 hours before the first dose of BIVV020
- If applicable, concurrent administration of ITP medications (eg. corticosteroids, IVIg, azathioprine, danazol, cyclosporin A, mycophenolate mofetil, or thrombopoietin receptor agonists) is acceptable provided the participant has been on a stable dose for at least 1 month.
- If previously dosed with rituximab, the last dose of rituximab must have been administered at least 12 weeks before the first dose of BIVV020
- Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis, including serogroup B where available, Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment
- Contraceptive use for women of childbearing potential and men who were sexually active with a female partner of childbearing potential
- Exclusion criteria:
- Participants were excluded from the study if any of the following criteria apply:
- Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his/her participation in the study
- Clinical diagnosis of SLE
- Clinically relevant infection within the month prior to enrollment
- History of venous or arterial thrombosis within the year prior to enrollment
- Secondary ITP from any cause including lymphoma, chronic lymphocytic leukemia, and drug-induced thrombocytopenia
- Positive hepatitis B surface antigen (HBsAg) or active HCV infection
- HIV infection
- Pregnant or lactating women
- Hemoglobin level \<10 g/dL
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04669600
Start Date
February 4 2021
End Date
February 7 2023
Last Update
September 10 2025
Active Locations (9)
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1
Investigational Site Number :8400001
Washington D.C., District of Columbia, United States, 20007
2
Investigational Site Number :8400002
Tamarac, Florida, United States, 33321
3
Investigational Site Number :2030002
Ostrava - Poruba, Czechia, 70852
4
Investigational Site Number :2760001
Essen, Germany, 45147