RecruitingPhase 1Phase 2NCT06721013

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

Sponsor

Eli Lilly and Company

Enrollment

68 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Immune Thrombocytopenia (ITP)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pirtobrutinib and a drug called Placebo for people with immune thrombocytopenia (itp). The study is currently recruiting participants at 45 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Administered orally

DRUGPlacebo

Administered orally

Locations(45)

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 Clinic Foundation

New Orleans, Louisiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Clinical Research Alliance

Westbury, New York, United States

Texas Oncology - Central South

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

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NCT06721013

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