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Clinical Trials in the USA / NCT05653349
Active, not recruiting Phase 3

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

NCT05653349 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-02-03
Last updated
2026-06-15

Condition(s) studied

Primary Immune Thrombocytopenia (ITP)

Investigational drug(s) / intervention(s)

IanalumabPlaceboCorticosteroids

Ianalumab: Intravenous infusion, prepared from concentrate solution

Placebo: Intravenous infusion, prepared from matching placebo

Corticosteroids: Oral or parental (if clinically justified)

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 increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Signed informed consent prior to participation in the study. * Male or female participants aged 18 years and older on the day of signing informed consent * Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG) * Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG) * Response (platelet count \>=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response. Key Exclusion Criteria: * Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible) * Current life-threatening bleeding * Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP . * Prior use of B-cell depleting therapy (e.g., rituximab). * Absolute neutrophil count below 1.0 G/L at randomization * Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid Other protocol-defined Inclusion/Exclusion may apply.

Primary outcome measure(s)

Trial sites (111)

FacilityCityRegionStatus
Yuma Regional Medical Center Yuma Arizona
Community Cancer Institute Clovis California
Compassionate Care Res Group Inc Fountain Valley California
University of Colorado Anschutz Aurora Colorado
DH Cancer Research Center LLC Margate Florida
Uni of Chi Medi Ctr Hema and Onco Chicago Illinois
Parkview Research Center Fort Wayne Indiana
Oncology Care Associates Bethesda Maryland
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Med Center Boston Massachusetts
Michigan Center of Medical Research Farmington Hills Michigan
Mayo Clinic Rochester Rochester Minnesota
Metro Minnesota CCOP Saint Louis Park Minnesota
St Vincent Frontier Cancer Center Billings Montana
Optum Health Lake Success New York
Hematology Oncology Association of Rockland Nyack New York
STAT Research Inc Dayton Ohio
Rhode Island Hospital Providence Rhode Island
Mays Cancer Ctr Uthsa Mdacc San Antonio Texas
Community Cancer Trials of Utah Ogden Utah
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site San Miguel Tucuman Tucumán Province
Novartis Investigative Site Caba Argentina
Novartis Investigative Site Córdoba Argentina
Novartis Investigative Site Garran Australian Capital Territory
Novartis Investigative Site Wooloongabba Queensland
Novartis Investigative Site Clayton Victoria
Novartis Investigative Site Melbourne Victoria
Novartis Investigative Site Innsbruck Tyrol
Novartis Investigative Site Salzburg Austria
Novartis Investigative Site Roeselare West-Vlaanderen
Novartis Investigative Site Brasschaat Belgium
Novartis Investigative Site Bruges Belgium
Novartis Investigative Site Leuven Belgium
Novartis Investigative Site Plovdiv Bulgaria
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Beijing Beijing Municipality
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Shenzhen Guangdong

+ 71 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05653349 on ClinicalTrials.gov ↗ ← All trials in the USA