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)
Start Date
8/4/2026
Completion Date
8/31/2030
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.
Detailed Description
The study will include an exploratory cohort of participants with primary Evans syndrome (ES) for whom IC TPO-RA therapy is appropriate per investigator's assessment. The study will consist of a 28-day screening period; a 16-week treatment period; an IC TPO-RA tapering period during which all participants will be monitored for 16 weeks. All participants will then continue to be followed for another 60-weeks (15 months) of long-term safety follow-up period.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ianalumab
thrombopoietin receptor agonist (TPO-RA)
Conditions
Locations
Highlands Oncology Group
Fayetteville, Arkansas 72703
United States
Yale Cancer Center
New Haven, Connecticut 06520
United States
Stamford Hospital
Stamford, Connecticut 06902
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
United States
DH Cancer Research Center LLC
Margate, Florida 33063
United States
University Of Miami
Miami, Florida 33136
United States
Hope And Healing Care
Hinsdale, Illinois 60521
United States
Pontchartrain Cancer Center
Covington, Louisiana 70433
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
University Health Kansas City
Kansas City, Missouri 64108
United States
Intermountain Healthcare
Billings, Montana 59102
United States
Astera Cancer Center
East Brunswick, New Jersey 08816
United States
Summit Medical Group
Summit, New Jersey 07901
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57106
United States
Utah Cancer Specialists
Salt Lake City, Utah 84106
United States