A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
NCT ID: NCT06721013
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
58 participants
INTERVENTIONAL
2025-07-30
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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Pirtobrutinib Phase 1
Pirtobrutinib administered orally
Pirtobrutinib
Administered orally
Pirtobrutinib Phase 2
Pirtobrutinib administered orally
Pirtobrutinib
Administered orally
Placebo Phase 2
Placebo administered orally
Placebo
Administered orally
Interventions
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Pirtobrutinib
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy
* Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
* Have a platelet count less than 30,000/μL on 2 occasions more than 5 days apart in the 15 days before randomization
* Have adequate liver, renal, and hematologic functions as defined by a table
* Are willing to follow contraception requirements
Exclusion Criteria
* Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization
* Have significant cardiovascular disease
* Have a diagnosis or history of hematologic malignancy
* Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA)
* Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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 Medical Center - New Orleans
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Clinical Research Alliance
Westbury, New York, United States
Texas Oncology-Central Austin
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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Related Links
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Lilly Trials
Other Identifiers
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27294
Identifier Type: -
Identifier Source: org_study_id
J2N-MC-JZNZ
Identifier Type: OTHER
Identifier Source: secondary_id
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