NCT05653349

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
BIOLOGICAL	Ianalumab	Intravenous infusion, prepared from concentrate solution
DRUG	Placebo	Intravenous infusion, prepared from matching placebo
DRUG	Corticosteroids	Oral or parental (if clinically justified)

Timeline

• Start date: 2023-02-03
• Primary completion: 2026-04-24
• Completion: 2028-09-07
• First posted: 2022-12-16
• Last updated: 2026-02-24

Locations

117 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, China, Czechia, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Mexico, Norway, Romania, Singapore, Spain, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study