Actively Recruiting
A Phase 1/2 Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
Led by Eli Lilly and Company · Updated on 2026-05-12
58
Participants Needed
45
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and efficacy of pirtobrutinib, an oral drug, in adults with Primary Immune Thrombocytopenia (ITP), a condition characterized by low platelet counts. The study includes two phases: phase 1 focuses on how well the drug is tolerated and the side effects that may occur, while phase 2 compares multiple doses of pirtobrutinib with a placebo to assess its effectiveness and safety. Eli Lilly and Company is leading this phase 1/2 clinical trial. Participants will receive pirtobrutinib or a placebo orally. Phase 1 involves a dose-escalation period lasting up to about 16 weeks, during which researchers monitor safety and side effects. Phase 2 is a dose-optimization period lasting up to 28 weeks, where different doses of pirtobrutinib are compared to placebo. Blood tests are performed to measure drug levels and elimination from the body. Throughout the study, participants undergo regular blood tests and clinical assessments to monitor treatment-emergent and treatment-related adverse events, including vital signs, laboratory tests, and electrocardiograms. The main outcomes measured include the number of side effects and the drug’s effectiveness compared to placebo. The study lasts approximately 16 weeks for phase 1 and 28 weeks for phase 2, excluding screening, with ongoing safety and efficacy evaluations.
CONDITIONS
Brief 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 Immune Thrombocytopenia (ITP) characterized by isolated low platelet count not linked to another disease
- Have a history of responding to at least one prior treatment with 2 or more platelet counts ≥50,000/microliter
- Have relapsed or treatment-resistant primary ITP with no effective available therapies
- Have platelet counts below 30,000/microliter on two occasions at least 5 days apart within 15 days before randomization
- Have adequate liver, kidney, and blood function as defined by study criteria
- Are willing to follow contraception requirements
You will not qualify if you...
- History of any blood clotting or embolic event within 12 months before screening
- Received blood transfusion or plasmapheresis within 14 days (Phase 1) or 28 days (Phase 2) before randomization
- Significant heart or cardiovascular disease
- Diagnosis or history of blood cancers
- Positive for hepatitis B infection by antigen or DNA test
- Positive for hepatitis C infection by antibody and RNA test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive either Pirtobrutinib or placebo administered orally as part of the study treatment.
Regular visits during treatment period
Duration - Up to 16 weeks after treatment
Participants are monitored for safety and additional outcomes after treatment ends.
Follow-up visits up to Week 40 depending on phase
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
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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