Back to Trials
NCT06721013PHASE1, PHASE2Recruiting

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Eli Lilly and Company

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

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)

Interventions

DRUG

Pirtobrutinib

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Immune Thrombocytopenia (ITP)

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