Faculty

Alexandra P. Wolanskyj-Spinner, M.D.

Clinical Studies

A Multi-center, Open-label, Single-arm Study To Evaluate The Efficacy And Safety Of Oral Rilzabrutinib In Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment Rochester, MN
This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.

A Phase 1/2, Dose-finding Study Investigating The Safety And Efficacy Of Pirtobrutinib In Adults With Immune Thrombocytopenia Rochester, MN The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.

The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.
A Phase 2 Open-label Study To Evaluate The Tolerability Of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) In Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With At Least One Treatment (VAY2EXPLORE) Rochester, MN 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.

A Phase III, Randomized, Double-blind Study Of Ianalumab (VAY736) Versus Placebo In Addition To First-line Corticosteroids In Primary Immune Thrombocytopenia (VAYHIT1) Rochester, MN
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥ 30 G/L in adult participants with primary ITP.