A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
NCT06876649 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 787
Last updated 2026-03-02
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.
Conditions
Interventions
- DRUG
-
Pirtobrutinib
Administered orally.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-20
- Primary Completion
- 2030-05-31
- Completion
- 2032-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- France
- Italy
- Japan
- Poland
- South Korea
- United Kingdom
Study Locations
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