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RecruitingPhase 1/Phase 2

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

Eli Lilly and Company · NCT06721013

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
68
US sites recruiting
8
Study start
July 30, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Pirtobrutinib; Placebo

Conditions: Immune Thrombocytopenia (ITP)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show 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)

Recruiting US locations

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia (NCT06721013) | Bored Studies