A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
- Immune Thrombocytopenia (ITP)
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 68
- Started
- 30 July 2025
- Main results due
- February 2028
- Study sites
- 43
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process * 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 at least 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: * Have a history of any thrombotic or embolic event within 12 months before screening * 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)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(43)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
Stanford University
Palo Alto, California, United States
Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Not yet recruiting
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Not yet recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
Texas Oncology - Central South
Austin, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Texas Oncology Gulf Coast
The Woodlands, Texas, United States
Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, China
Not yet recruiting
Qilu Hospital of Shandong University
Jinan, China
Not yet recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China
Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Not yet recruiting
OUH
Odense C, Denmark
Recruiting
Hôpital Henri Mondor
Créteil, France
Recruiting
CHU Dijon - Hopital du Bocage
Dijon, France
Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy
Recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, Italy
Not yet recruiting
Haukeland University Hospital
Bergen, Norway
Not yet recruiting
Sykehuset Ostfold, Kalnes
Grålum, Norway
Not yet recruiting
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trondheim, Norway
Not yet recruiting
Pratia Onkologia Katowice
Katowice, Poland
Recruiting
Pratia MCM Krakow
Krakow, Poland
Recruiting
Aidport sp z o.o.
Skorzewo, Poland
Recruiting
MICS Centrum Medyczne Torun
Torun, Poland
Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland
Not yet recruiting
Pusan National University Hospital
Busan, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Recruiting
Hospital Clinic de Barcelona
Barcelona, Spain
Recruiting
Hospital Universitario de Burgos
Burgos, Spain
Recruiting
Hospital General Universitario Morales Meseguer
Murcia, Spain
Recruiting
Clinica Universidad de Navarra
Pamplona, Spain
Recruiting
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Recruiting
St James's University Hospital
Leeds, United Kingdom
Recruiting
Leicester Royal Infirmary
Leicester, United Kingdom
Recruiting
Royal London Hospital
London, United Kingdom
Not yet recruiting
Hammersmith Hospital
London, United Kingdom
Not yet recruiting
Showing 43 of 43 sites. 30 of the 43 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06721013. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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