Actively Recruiting
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Led by Eli Lilly and Company · Updated on 2026-05-12
58
Participants Needed
45
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (bcL), 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/bcL 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94305-5406
Not Yet Recruiting
3
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Not Yet Recruiting
5
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61614
Not Yet Recruiting
6
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
8
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
9
Texas Oncology - Central South
Austin, Texas, United States, 78758
Not Yet Recruiting
10
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Texas Oncology Gulf Coast
The Woodlands, Texas, United States, 77380
Not Yet Recruiting
12
Nanfang Hospital of Southern Medical University
Guangzhou, China, 510515
Not Yet Recruiting
13
Qilu Hospital of Shandong University
Jinan, China, 250012
Not Yet Recruiting
14
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China, 300020
Not Yet Recruiting
15
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430022
Not Yet Recruiting
16
OUH
Odense C, Denmark, 5000
Actively Recruiting
17
Hôpital Henri Mondor
Créteil, France, 94010
Actively Recruiting
18
CHU Dijon - Hopital du Bocage
Dijon, France, 21034
Actively Recruiting
19
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
20
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy, 40138
Actively Recruiting
21
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
22
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
23
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, Italy, 34129
Not Yet Recruiting
24
Haukeland University Hospital
Bergen, Norway, 5021
Not Yet Recruiting
25
Sykehuset Ostfold, Kalnes
Grålum, Norway, 1714
Not Yet Recruiting
26
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trondheim, Norway, 7030
Not Yet Recruiting
27
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
28
Pratia MCM Krakow
Krakow, Poland, 30-727
Actively Recruiting
29
Aidport sp z o.o.
Skorzewo, Poland, 60-185
Actively Recruiting
30
MICS Centrum Medyczne Torun
Torun, Poland, 87-100
Actively Recruiting
31
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland, 50-367
Not Yet Recruiting
32
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
33
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
34
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
35
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
36
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
37
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
38
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
39
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
40
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
41
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
42
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
43
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
44
Royal London Hospital
London, United Kingdom, E1 1FR
Not Yet Recruiting
45
Hammersmith Hospital
London, United Kingdom, W12 0HS
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here