Clinical Trials in Poland / NCT05885555
Active, not recruiting
Phase 2
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
NCT05885555 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Primary Immune Thrombocytopenia (ITP)
Investigational drug(s) / intervention(s)
Ianalumab: Intravenous infusion, prepared from concentrate solution
Study summary
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
Eligibility
Inclusion Criteria:
* Signed informed consent obtained prior to participation in the study.
* Male or female participants aged 18 years and older on the day of signing informed consent.
* Confirmed diagnosis of primary ITP.
* Prior treatment with at least a corticosteroid (±IVIG) and a TPO-RA:
* Prior additional therapies are allowed; the corticosteroid or the TPO-RA do not need to be the last treatment.
* Prior response to IVIG/anti-D or a corticosteroid (platelet count ≥50 G/L) that was not maintained.
* At last ITP treatment, loss of response, insufficient response, no response or intolerance.
* Platelet count \<30 G/L and assessed as needing treatment (per physician's discretion) at screening. If concomitant ITP medication is clinically indicated, the platelet assessment showing a value \<30 G/L must be performed after at least 14 days on a stable dose of a corticosteroid or/and a TPO-RA (less than 10% variation from current dose) and continue stable thereafter.
Key exclusion criteria:
* Diagnosis of secondary thrombocytopenia.
* Platelet or whole blood transfusion, plasmapheresis, or use of any other rescue medications within 14 days before first ianalumab infusion.
* Participants with the following conditions at screening:
* Neutrophils \<1000/mm3.
* Immunoglobulin G (IgG) \<5 g/L
* Treatment with a B-cell depleting therapy (e.g., rituximab) or anti-B-cell Activating Factor of the TNF Family (BAFF) (e.g., belimumab) within 12 weeks prior to the first administration of ianalumab.
* Immunosuppressant drugs other than corticosteroids within 5 times the elimination half-life of the drug or 14 days before first ianalumab infusion, whichever is longer.
* Prior splenectomy.
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Confirmed response — Between Week 1 Day 1 and Week 25 Day 1
Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of: * Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and * New immune thrombocytopenia (ITP) treatment before reaching a confirmed response.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | |
| Beth Israel Deaconess Med Center | Boston | Massachusetts | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | Garran | Australian Capital Territory | |
| Novartis Investigative Site | Melbourne | Victoria | |
| Novartis Investigative Site | Wuhan | Hubei | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Jinan | China | |
| Novartis Investigative Site | Toulouse | France | |
| Novartis Investigative Site | Dresden | Saxony | |
| Novartis Investigative Site | Jena | Thuringia | |
| Novartis Investigative Site | Giessen | Germany | |
| Novartis Investigative Site | Torino | TO | |
| Novartis Investigative Site | Johor Bahru | Malaysia | |
| Novartis Investigative Site | Katowice | Poland | |
| Novartis Investigative Site | Seoul | South Korea | |
| Novartis Investigative Site | Barcelona | Catalonia | |
| Novartis Investigative Site | Aydin | Efeler | |
| Novartis Investigative Site | Istanbul | Fatih | |
| Novartis Investigative Site | Edirne | Merkez | |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) | |
| Novartis Investigative Site | Kocaeli | Turkey (Türkiye) | |
| Novartis Investigative Site | Glasgow | United Kingdom | |
| Novartis Investigative Site | London | United Kingdom |
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Official registry record
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 NCT05885555 on ClinicalTrials.gov ↗ ← All trials in Poland