Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
Condition(s) studied
Investigational drug(s) / intervention(s)
Ianalumab: Concentrate for solution for infusion for intravenous use
Study summary
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).
Eligibility
Primary outcome measure(s)
- Treatment failure free (yes, no) for participants with Immune Thrombocytopenia (ITP) — From treatment start date until the events indicative of treatment failure (up to 2 years after last dose)
Treatment failure free (yes, no) by 12 months after start of second course of ianalumab at assigned dose. - Durable response for participants with Warm Autoimmune Hemolytic Anemia (wAIHA) — At least 8 consecutive weeks, between week 9 and week 25
Durable response (hemoglobin (Hb) ≥10 g/dL and ≥2 g/dL increase from baseline) for a period of at least 8 consecutive weeks, between W9 and W25 in the absence of rescue or prohibited treatment prior to that durable response achievement.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Buenos Aires | Argentina | Withdrawn |
| Novartis Investigative Site | Roeselare | West-Vlaanderen | Recruiting |
| Novartis Investigative Site | Guangzhou | Guangdong | Recruiting |
| Novartis Investigative Site | Dalian | Liaoning | Recruiting |
| Novartis Investigative Site | Tianjin | China | Recruiting |
| Novartis Investigative Site | Ostrava | Poruba | Recruiting |
| Novartis Investigative Site | Caen | France | Recruiting |
| Novartis Investigative Site | Rennes | France | Recruiting |
| Novartis Investigative Site | Jena | Thuringia | Recruiting |
| Novartis Investigative Site | Debrecen | Hajdu Bihar Megye | Recruiting |
| Novartis Investigative Site | Florence | FI | Recruiting |
| Novartis Investigative Site | Roma | RM | Recruiting |
| Novartis Investigative Site | Trieste | TS | Recruiting |
| Novartis Investigative Site | Vicenza | VI | Recruiting |
| Novartis Investigative Site | George Town | Malaysia | Recruiting |
| Novartis Investigative Site | Johor Bahru | Malaysia | Recruiting |
| Novartis Investigative Site | Kuala Selangor | Malaysia | Recruiting |
| Novartis Investigative Site | Bucharest | Romania | Recruiting |
| Novartis Investigative Site | Singapore | Singapore | Recruiting |
| Novartis Investigative Site | Barcelona | Spain | Recruiting |
| Novartis Investigative Site | Madrid | Spain | Recruiting |
| Novartis Investigative Site | Murcia | Spain | Recruiting |
| Novartis Investigative Site | Samsun | Atakum | Recruiting |
| Novartis Investigative Site | Ankara | Bilkent Cankaya | Recruiting |
| Novartis Investigative Site | London | United Kingdom | Recruiting |
More Novartis Pharmaceuticals trials in Turkey
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 NCT07039422 on ClinicalTrials.gov ↗ ← All trials in Turkey