drugset / Trial / NCT06876649

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

NCT06876649

Phase 4 Recruiting 787 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

Summary

The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.

Timeline

Start
2025-05-20
Primary completion
2030-05
Completion
2032-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pirtobrutinib Other / unclassified Oral