A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Time from randomization until treatment failure — Randomization to until end of study (up to 39 months after randomization of last participant)
Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: * platelet count below 30 G/L * start of a new ITP treatment * need for a rescue treatment * ineligibility to taper or inability to discontinue eltrombopag * death
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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 NCT05653219 on ClinicalTrials.gov ↗ ← All trials in Italy