Last updated on November 2019

A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)

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Brief description of study

This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/L on two counts no sooner than 7 days apart in the 15 days before treatment begins.

Detailed Study Description

This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term extension.