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

NCT05653219 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2025-06-19
Completion
2028-04-08
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653219 on ClinicalTrials.gov