An upcoming study will investigate the therapeutic profile and characteristics of ianalumab as a potential treatment for immune thrombocytopenia (ITP).
Researchers will soon initiate the recruiting process for this interventional study. This open-label, single-arm, phase 2 clinical trial will include approximately 400 participants diagnosed with ITP who have previously undergone treatment with traditional alternatives.
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The authors will observe and report the efficacy, safety, and tolerability of ianalumab in patients with a platelet count below 30 G/L. All participants must have attempted treatment with at least a steroid and 1 or more thrombopoietin receptor agonists.
The study consists of an initial screening phase for approximately 14 days, followed by the primary endpoint assessment stage. Finally, the follow-up period, which will end 24 months after the first dose of ianalumab, will monitor safety-related data. Patients who maintain a platelet count above 30 G/L without another therapeutic approach will also participate in efficacy monitoring.
All individuals will receive the same dose of ianalumab, administered intravenously. The authors aim to report the proportion of cases that achieve a confirmed response to ianalumab as the primary outcome. The study defines this as a platelet count of 50 G/L or more in at least 2 consecutive evaluations, separated by a minimum of 7 days. Patients in this category cannot have received either rescue treatment in the previous 4 weeks or another ITP treatment.
Moreover, the authors will assess the time to a confirmed response and its duration, the complete response and response rates at each time point, and the percentage of patients with a stable response at 6 and 12 months as secondary outcomes regarding efficacy.
The investigators will collect safety information such as the number and percentage of participants who present with bleeding events or require rescue treatment. Other secondary outcomes include the change from baseline and time to recovery of CD19+ B-cell counts, the change from baseline in immunoglobulins, the incidence of anti-ianalumab antibodies, and ianalumab serum concentration over time.
Individuals aged 18 years and above of both sexes who have a confirmed diagnosis of ITP and insufficient response to previous therapies are welcome to participate.
This novel research, titled “A study of ianalumab (VAY736) in patients with primary immune thrombocytopenia (ITP) previously treated with at least two lines of therapies,” will begin in August 2023. It is expected to be completed by October 2026.
A study of ianalumab (VAY736) in patients with primary immune thrombocytopenia (ITP) previously treated with at least two lines of therapies. ClinicalTrials.gov. June 2, 2023. Updated June 7, 2023. Accessed June 16, 2023.