A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.

Eligibility criteria

Qualifiers

Signed informed consent must be obtained prior to participation in the study.

Patients aged 18 years and older on the day of signing the informed consent.

ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G/L).

ITP cohort only: Received at least one prior treatment for ITP.

Disqualifiers

Patients being treated with TPO-RA for > 6 months.

Current life-threatening bleeding (related to thrombocytopenia).

Prior splenectomy within 6 months of first administration of ianalumab.

Neutrophils: < 1000/mm3

Trial design

Treatments tested in this trial

  • ianalumab
  • thrombopoietin receptor agonist (TPO-RA)

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators