MedTrace Logo

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

NCT05653349 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Interventions

BIOLOGICAL

Ianalumab

Intravenous infusion, prepared from concentrate solution

DRUG

Placebo

Intravenous infusion, prepared from matching placebo

DRUG

Corticosteroids

Oral or parental (if clinically justified)

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
2023-02-03
Primary Completion
2026-10-29
Completion
2028-12-06
FDA Drug
Yes

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

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 NCT05653349 on ClinicalTrials.gov