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Looking for participantsPhase1/Phase2

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Sponsor: Eli Lilly and Company

NCT ID: NCT06721013

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pirtobrutinib (drug), Placebo (drug)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Pirtobrutinib — drug: Administered orally · Placebo — drug: Administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
68
Started
2025-07-30
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for immune thrombocytopenia (itp)
  • • Phase1/Phase2 - 68 participants
  • • The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with immune thrombocytopenia (itp)

Where?

  • • Bristol - Bristol Haematology and Oncology Centre
  • • Leeds - St James's University Hospital
  • • Leicester - Leicester Royal Infirmary
  • • London - Royal London Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Immune Thrombocytopenia (ITP)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

defined as positivePCR positive

Treatment history

Treatments you must have had:

  • ✓ of therapy

What the study is looking for

  • ✓Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process
  • ✓Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
  • ✓Have a blood clotting cell count less than 30,000/μL on 2 occasions at least 5 days apart in the 15 days before randomization
  • ✓Have adequate liver, kidney, and blood functions as defined by a table
  • ✓Are willing to follow contraception requirements

Who cannot take part

  • ✗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...
  • ✗Have significant cardiovascular disease
  • ✗Have a diagnosis or history of blood cancer
  • ✗Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction...
See the full criteria
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)

Where Is This Study? (5 UK sites)

Bristol Haematology and Oncology Centre

Bristol BS2 8ED, United Kingdom

Recruiting

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Royal London Hospital

London E1 1FR, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Hammersmith Hospital

London W12 0HS, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10