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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Primary Immune Thrombocytopenia (ITP)
  • Purpura, Thrombocytopenic, Idiopathic
  • Thrombocytopenia

NCT number NCT05653349
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Status Recruiting
Phase Phase 3
Start date March 6, 2023
Completion date February 4, 2028

See also
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Recruiting NCT05885555 - A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies Phase 2
Recruiting NCT04518475 - Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults Phase 4