The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.
Signed informed consent must be obtained prior to participation in the study.
Patients aged 18 years and older on the day of signing the informed consent.
ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G/L).
ITP cohort only: Received at least one prior treatment for ITP.
Patients being treated with TPO-RA for > 6 months.
Current life-threatening bleeding (related to thrombocytopenia).
Prior splenectomy within 6 months of first administration of ianalumab.
Neutrophils: < 1000/mm3
Parallel
ianalumab
Biological/Vaccine9 mg per kilogram infusion every 4 weeks (Q4W) for 16 weeks
thrombopoietin receptor agonist (TPO-RA)
DrugIC TPO-RAs will be administered according to the respective United States Prescribing Information (USPIs)
(Main cohort: Primary immune thrombocytopenia (ITP)): Percentages of participants who are tolerable to ianalumab (9 mg/kg)
The proportion of participants who tolerate ianalumab (9 mg/kg) is defined as those who do not experience any of the following events during the combination treatment period (up to Week 16): * Discontinuation due to an adverse event (AE) unrelated to efficacy * Adverse events leading to dose reduction or dose rate reduction * Adverse events resulting in study drug interruption.
(Main cohort: Primary immune thrombocytopenia (ITP)): Incidence rate of Adverse Events
The distribution of adverse events will be conducted through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters.
(Main cohort: Primary immune thrombocytopenia (ITP)): Percentage of participants with platelet count ≥ 30 G/L, ≥ 50 G/L, ≥ 100 G/L
Platelet count will be measured as part of routine hematology safety assessments
(Main cohort: Primary immune thrombocytopenia (ITP)): Change from baseline in platelet count for prespecified subgroups (<30, 30 to 50, 50 to <100 G/L)
Platelet count will be measured as part of routine hematology safety assessments
(Main cohort: Primary immune thrombocytopenia (ITP)): Percentage of participants with successful IC TPO-RA tapering
Tapering of investigator's choice thrombopoietin receptor agonist (IC TPO-RA) will be evaluated based on the proportion of participants who successfully discontinue IC TPO-RA without requiring rescue therapy or new immune thrombocytopenia (ITP) treatments by the end of the tapering period. A participant is considered successfully tapered if all of the following criteria are met: * Discontinuation of IC TPO-RA before Week 33 Day 1 (W33D1) with at least two consecutive platelet counts ≥ 30 G/L from separate visits. * No use of rescue treatment or initiation of new ITP therapy in the 4 weeks prior to W33D1.
Click on the lead sponsor to view all of their trials.
