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A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Sponsor: Eli Lilly and Company
Summary
The purpose of the phase 1 part of this study is 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.
Official title: A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2025-07-30
Completion Date
2027-02
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Pirtobrutinib
Administered orally
Placebo
Administered orally
Locations (45)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Ochsner Clinical Foundation
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Clinical Research Alliance
Westbury, New York, United States
Texas Oncology - Central South
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology Gulf Coast
The Woodlands, Texas, United States
Nanfang Hospital of Southern Medical University
Guangzhou, China
Qilu Hospital of Shandong University
Jinan, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
OUH
Odense C, Denmark
Hôpital Henri Mondor
Créteil, France
CHU Dijon - Hopital du Bocage
Dijon, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, Italy
Haukeland University Hospital
Bergen, Norway
Sykehuset Ostfold, Kalnes
Grålum, Norway
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trondheim, Norway
Pratia Onkologia Katowice
Katowice, Poland
Pratia MCM Krakow
Krakow, Poland
Aidport sp z o.o.
Skorzewo, Poland
MICS Centrum Medyczne Torun
Torun, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland
Pusan National University Hospital
Busan, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal London Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom