RecruitingPhase 2NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)

A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)


Sponsor

Novartis Pharmaceuticals

Enrollment

164 participants

Start Date

Aug 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ianalumab and a drug called thrombopoietin receptor agonist (TPO-RA) for people with primary evans syndrome (es) and primary immune thrombocytopenia (itp). The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALianalumab

9 mg per kilogram infusion every 4 weeks (Q4W) for 16 weeks

DRUGthrombopoietin receptor agonist (TPO-RA)

IC TPO-RAs will be administered according to the respective United States Prescribing Information (USPIs)


Locations(13)

Highlands Oncology Group

Fayetteville, Arkansas, United States

Stamford Hospital

Stamford, Connecticut, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

DH Cancer Research Center LLC

Margate, Florida, United States

University Of Miami

Miami, Florida, United States

Hope And Healing Care

Hinsdale, Illinois, United States

Pontchartrain Cancer Center

Covington, Louisiana, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Intermountain Healthcare

Billings, Montana, United States

Summit Medical Group

Summit, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07421167


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