A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Start Date
7/30/2025
Completion Date
5/1/2029
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 Criteria
Age Range: 18 years to No maximum
Interventions
Pirtobrutinib
Placebo
Conditions
Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Stanford University
Stanford, California 94305-5406
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois 61614
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Clinical Research Alliance
Westbury, New York 11590
United States
Texas Oncology - Central South
Austin, Texas 78758
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Texas Oncology Gulf Coast
The Woodlands, Texas 77380
United States
Nanfang Hospital of Southern Medical University
Guangzhou, 510515
China
Qilu Hospital of Shandong University
Jinan, 250012
China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, 300020
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
China
OUH
Odense C, 5000
Denmark
Hôpital Henri Mondor
Créteil, 94010
France
CHU Dijon - Hopital du Bocage
Dijon, 21034
France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
France
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, 34129
Italy
Haukeland University Hospital
Bergen, 5021
Norway
Sykehuset Ostfold, Kalnes
Grålum, 1714
Norway
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trondheim, 7030
Norway
Pratia Onkologia Katowice
Katowice, 40-519
Poland
Pratia MCM Krakow
Krakow, 30-727
Poland
Aidport sp z o.o.
Skorzewo, 60-185
Poland
MICS Centrum Medyczne Torun
Torun, 87-100
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367
Poland
Pusan National University Hospital
Busan, 49241
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South Korea
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Universitario de Burgos
Burgos, 09006
Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008
Spain
Clinica Universidad de Navarra
Pamplona, 31008
Spain
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
United Kingdom
St James's University Hospital
Leeds, LS9 7TF
United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW
United Kingdom
Royal London Hospital
London, E1 1FR
United Kingdom
Hammersmith Hospital
London, W12 0HS
United Kingdom