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Clinical Trials in India / NCT05653219
Active, not recruiting Phase 3

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

NCT05653219 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-02-02
Last updated
2026-08-21

Condition(s) studied

Primary Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

IanalumabEltrombopagPlacebo

Ianalumab: Concentrate for solution for infusion for intravenous use

Eltrombopag: Film-coated tablet for oral use

Placebo: Concentrate for solution for infusion for intravenous use.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion criteria 1. Male or female patients aged 18 years and older on the day of signing the informed consent. 2. A signed informed consent must be obtained prior to participation in the study. 3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG. 4. Patient with platelet count \<30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag Key Exclusion criteria 1. ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible. 2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible). 3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters 4. Patients with current or history of life-threatening bleeding 5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given 6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period 7. Patients with hepatic impairment 8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily) 9. Nursing (breast feeding) or pregnant women Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Yuma Regional Medical Center Yuma Arizona
University of Colorado Anschutz Aurora Colorado
NorthShore University Health System Evanston Illinois
Boston Medical Center Boston Massachusetts
UMASS Memorial Medical Center Worcester Massachusetts
Michigan Center of Medical Research Farmington Hills Michigan
St Vincent Frontier Cancer Center Billings Montana
Hematology Oncology Association of Rockland Nyack New York
Montefiore Medical Center The Bronx New York
Novartis Investigative Site CABA Argentina
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Yvoir Namur
Novartis Investigative Site Roeselare West-Vlaanderen
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Wuhan Hubei
Novartis Investigative Site Binzhou Shandong
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Beijing China
Novartis Investigative Site Jinan China
Novartis Investigative Site Tianjin China
Novartis Investigative Site Brno Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Blois France
Novartis Investigative Site Le Mans France
Novartis Investigative Site Cologne North Rhine-Westphalia
Novartis Investigative Site Dresden Saxony
Novartis Investigative Site Jena Thuringia
Novartis Investigative Site Dresden Germany
Novartis Investigative Site Debrecen Hajdu Bihar Megye
Novartis Investigative Site Budapest Hungary
Novartis Investigative Site Rishikesh Uttarakhand
Novartis Investigative Site Kolkata West Bengal
Novartis Investigative Site Bologna BO
Novartis Investigative Site Roma RM
Novartis Investigative Site Roma RM
Novartis Investigative Site Trieste TS
Novartis Investigative Site Nagoya Aichi-ken
Novartis Investigative Site Osaka Osaka
Novartis Investigative Site Suita Osaka

+ 34 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 NCT05653219 on ClinicalTrials.gov ↗ ← All trials in India