Evaluating Oral Pirtobrutinib for Adults with Immune Thrombocytopenia A Phase 12 Study on Safety and Efficacy

What this Trial Is About

Researchers are studying pirtobrutinib, an oral drug, in adults with Primary Immune Thrombocytopenia ITP, a condition where the immune system reduces platelet counts. The study includes a Phase 1 dose-escalation to evaluate tolerability and side effects, followed by a Phase 2 dose-optimization to further assess efficacy and safety compared to a placebo. This research aims to find safe and effective doses for managing ITP. Participants receive pirtobrutinib orally or a placebo in a randomized, double-blind design. Phase 1 lasts about 16 weeks focusing on dose escalation, while Phase 2 lasts about 28 weeks for dose optimization. Blood tests are performed to measure drug levels and how the body clears it. During Phase 2, participants may receive different dosages of pirtobrutinib or placebo to compare effects. Throughout the study, participants undergo blood tests and clinical assessments to monitor safety, including adverse events, vital signs, lab tests, and electrocardiograms. Efficacy is measured by platelet counts and disease control over up to 24 weeks. The study also tracks how pirtobrutinib behaves in the body. Participation lasts up to 28 weeks excluding screening, with close monitoring for safety and response.

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia