New pill could help ITP patients who failed other treatments
NCT ID NCT06721013
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called pirtobrutinib in adults with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding risks. The trial has two parts: first, finding safe doses, then comparing pirtobrutinib to a placebo to see if it raises platelet counts. About 68 people who have not responded to prior treatments will take the pill daily for up to 28 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pirtobrutinib
- What this could lead to
- If it works, this could offer a new oral treatment option for adults with ITP who have not responded to other therapies.
- What could go wrong
- This is an early phase 1/2 trial with only 68 participants, so results may not apply to everyone. Side effects and lack of efficacy are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Immune thrombocytopenia (ITP) are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
45 sites in 10 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aidport sp z o.o.
RECRUITINGSkorzewo, 60-185, Poland
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
RECRUITINGBologna, 40138, Italy
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Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
NOT_YET_RECRUITINGTrieste, 34129, Italy
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Bleeding and Clotting Disorders Institute
NOT_YET_RECRUITINGPeoria, Illinois, 61614, United States
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Bristol Haematology and Oncology Centre
RECRUITINGBristol, BS2 8ED, United Kingdom
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CHU Bordeaux - Hôpital Haut-Lévêque
RECRUITINGPessac, 33604, France
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CHU Dijon - Hopital du Bocage
RECRUITINGDijon, 21034, France
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Clinica Universidad de Navarra
RECRUITINGPamplona, 31008, Spain
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Clinical Research Alliance
RECRUITINGWestbury, New York, 11590, United States
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Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
RECRUITINGMilan, 20122, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, 00168, Italy
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Hammersmith Hospital
NOT_YET_RECRUITINGLondon, W12 0HS, United Kingdom
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Haukeland University Hospital
NOT_YET_RECRUITINGBergen, 5021, Norway
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Hematology Hospital of the Chinese Academy of Medical Sciences
NOT_YET_RECRUITINGTianjin, 300020, China
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Hospital Clinic de Barcelona
RECRUITINGBarcelona, 08036, Spain
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Hospital General Universitario Morales Meseguer
RECRUITINGMurcia, 30008, Spain
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Hospital Universitario de Burgos
RECRUITINGBurgos, 09006, Spain
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Hôpital Henri Mondor
RECRUITINGCréteil, 94010, France
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Leicester Royal Infirmary
RECRUITINGLeicester, LE1 5WW, United Kingdom
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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MICS Centrum Medyczne Torun
RECRUITINGTorun, 87-100, Poland
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Mayo Clinic
NOT_YET_RECRUITINGRochester, Minnesota, 55905, United States
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MedStar Georgetown University Hospital
RECRUITINGWashington D.C., District of Columbia, 20007, United States
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Nanfang Hospital of Southern Medical University
NOT_YET_RECRUITINGGuangzhou, 510515, China
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OUH
RECRUITINGOdense C, 5000, Denmark
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Ochsner Clinic Foundation
RECRUITINGNew Orleans, Louisiana, 70121, United States
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Pratia MCM Krakow
RECRUITINGKrakow, 30-727, Poland
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Pratia Onkologia Katowice
RECRUITINGKatowice, 40-519, Poland
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Pusan National University Hospital
RECRUITINGBusan, 49241, South Korea
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Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, 250012, China
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Royal London Hospital
NOT_YET_RECRUITINGLondon, E1 1FR, United Kingdom
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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St James's University Hospital
RECRUITINGLeeds, LS9 7TF, United Kingdom
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St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
NOT_YET_RECRUITINGTrondheim, 7030, Norway
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Stanford University
NOT_YET_RECRUITINGStanford, California, 94305-5406, United States
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Sykehuset Ostfold, Kalnes
NOT_YET_RECRUITINGGrålum, 1714, Norway
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Texas Oncology - Central South
NOT_YET_RECRUITINGAustin, Texas, 78758, United States
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Texas Oncology Gulf Coast
NOT_YET_RECRUITINGThe Woodlands, Texas, 77380, United States
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The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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USC Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, 430022, China
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University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
NOT_YET_RECRUITINGMiami, Florida, 33136, United States
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
NOT_YET_RECRUITINGWroclaw, 50-367, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Donor CAR-T cells aim to reset a misguided immune system
- Real-World data may reveal which ITP treatments work best
- What Trade-Offs are ITP patients willing to make for better treatment?
- Can an RNA 'Message' reprogram the immune system to stop autoimmune blood disorders?
- Can a bispecific antibody tame two autoimmune blood disorders?
- Can a gut bacteria transplant help when steroids fail for a bleeding disorder?