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

NCT05885555

Active Not RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Primary Immune Thrombocytopenia (ITP)

Interventions: Ianalumab

Countries: United States, Argentina, Australia, China, France, Germany, Italy, Malaysia

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (24)
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • CABA, Argentina
  • Garran, Australian Capital Territory, Australia
  • Melbourne, Victoria, Australia
  • Wuhan, Hubei, China
  • Beijing, China
  • Jinan, China
  • Toulouse, France
  • Dresden, Saxony, Germany
  • Jena, Thuringia, Germany
  • Giessen, Germany
  • Torino, TO, Italy
  • Johor Bahru, Malaysia
  • Katowice, Poland
  • Seoul, South Korea
  • Barcelona, Catalonia, Spain
  • Aydin, Efeler, Turkey (Türkiye)
  • Istanbul, Fatih, Turkey (Türkiye)
  • Edirne, Merkez, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
  • Kocaeli, Turkey (Türkiye)
  • Glasgow, United Kingdom
  • London, United Kingdom