A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies

Running, not enrolling · Phase 2

Conditions studied: Primary Immune Thrombocytopenia (ITP)

In brief

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.

Key facts

Study ID

NCT05885555

Run by

Novartis Pharmaceuticals

People needed

41

Starts

2023-08-16

Expected to finish

2029-03-19

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Center — Boston, Massachusetts, United States
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Garran, Australian Capital Territory, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Wuhan, Hubei, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Jinan, China
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Dresden, Saxony, Germany
• Novartis Investigative Site — Jena, Thuringia, Germany
• Novartis Investigative Site — Giessen, Germany
• Novartis Investigative Site — Torino, TO, Italy
• Novartis Investigative Site — Johor Bahru, Malaysia
• Novartis Investigative Site — Katowice, Poland
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Aydin, Efeler, Turkey (Türkiye)
• Novartis Investigative Site — Istanbul, Fatih, Turkey (Türkiye)
• Novartis Investigative Site — Edirne, Merkez, Turkey (Türkiye)
• Novartis Investigative Site — Izmir, Turkey (Türkiye)
• Novartis Investigative Site — Kocaeli, Turkey (Türkiye)
• Novartis Investigative Site — Glasgow, United Kingdom
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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