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Clinical Trials in the UK / 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 UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2023-08-16
Last updated
2026-09-11

Condition(s) studied

Primary Immune Thrombocytopenia (ITP)

Investigational drug(s) / intervention(s)

Ianalumab

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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)

Trial sites (24)

FacilityCityRegionStatus
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
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 the UK