Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Rate of Stable Response off treatment at 12 months (SROT-12) — 12 months after last patient completed treatment
A participant will be considered in SROT-12 if at least 75% of the platelet counts collected between visits Week 53 Day 1 and Week 65 Day 1 (Study Days 352 and 463) qualify as Response. Response is any platelet counts of at least 50 G/L in the absence of rescue treatment or new immune thrombocytopenia (ITP) treatment).
Trial sites (111)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Novartis Pharmaceuticals trials in Italy
Other trials for the same condition
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 Italy