Print

Purpose

The purpose of the phase 1 part of this study is 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 more than 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)

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1-Open label Sequential, Phase 2-Double-blind Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)
Masking Description
Phase 1-Open label, Phase 2-Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pirtobrutinib Phase 1 		Pirtobrutinib administered orally
  • Drug: Pirtobrutinib
    Administered orally
Experimental
Pirtobrutinib Phase 2 		Pirtobrutinib administered orally
  • Drug: Pirtobrutinib
    Administered orally
Placebo Comparator
Placebo Phase 2 		Placebo administered orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.