NCT05653219

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (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 added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

Detailed description

This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count \<30 G/L) who failed previous first-line treatment with corticosteroids. After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.

Conditions

• Primary Immune Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	Ianalumab	Concentrate for solution for infusion for intravenous use
DRUG	Eltrombopag	Film-coated tablet for oral use
DRUG	Placebo	Concentrate for solution for infusion for intravenous use.

Timeline

• Start date: 2023-02-02
• Primary completion: 2025-06-19
• Completion: 2028-04-08
• First posted: 2022-12-16
• Last updated: 2026-03-31

Locations

74 sites across 24 countries: United States, Argentina, Austria, Belgium, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study