Michigan Center of Medical Research | Farmington Hills, MI
Status and phase
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About
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Full description
This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary ITP (platelets count <30 G/L) who require first-line standard-of-care corticosteroids.
After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids).
After the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply.
Primary purpose
Allocation
Interventional model
Masking
225 participants in 3 patient groups, including a placebo group
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Central trial contact
Novartis Pharmaceuticals; Novartis Pharmaceuticals
Data sourced from clinicaltrials.gov
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