A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Condition(s) studied

Investigational drug(s) / intervention(s)

Pirtobrutinib: Administered orally

Placebo: Administered orally

Study summary

The purpose of the phase 1 part of this study was 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.

Eligibility

Primary outcome measure(s)

• Phase 1-Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline Up to Week 4
  A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
• Phase 1-Dose Limiting Toxicity (DLT) of Pirtobrutinib — Baseline Up to Week 4
  DLTs of Pirtobrutinib
• Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Vital Signs: Blood Pressure, Pulse Rate, and Body Temperature — Baseline Up to Week 16
  Blood Pressure, Pulse Rate, and Body Temperature
• Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Clinical Lab Tests: Hematology, Clinical Chemistry, Urinalysis, Pregnancy, Hepatitis Serology and Cytomegalovirus (CMV) — Baseline Up to Week 16
  Hematology, Clinical Chemistry, Urinalysis, Pregnancy, Hepatitis Serology and Cytomegalovirus (CMV)
• Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Electrocardiograms (ECGs): ECG QT Interval — Baseline Up to Week 16
  ECG QT Interval
• Phase 2-Efficacy of Pirtobrutinib Versus Placebo — Baseline Up to Week 24
  Stable platelet response rate is defined as the proportion of participants achieving platelet count of greater than or equal to 50 thousand per microliter (k/μL) and on at least 4 of the 6 consecutive biweekly visits between weeks 14 and 24 in the absence of rescue therapy and prohibited concomitant medication that may impact efficacy

Trial sites (45)

+ 5 more sites — see the full list on the official registry below.

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