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)
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.