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)
Recruiting
Phase 2
Interventional Study
Primary Immune Thrombocytopenia (ITP)
Primary Evans Syndrome (ES)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 164 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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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 ianaluma…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* 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 I…
Contacts