Pirtobrutinib for Immune Thrombocytopenic Purpura

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Eli Lilly and Company

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Primary Immune Thrombocytopenia (ITP), a condition where the immune system destroys platelets. Participants must meet specific health criteria, which are not detailed here.

Inclusion Criteria

My platelet counts improved to 50,000 or more after treatment.

My ITP has not improved with treatment and no other treatments are likely to help.

I have been diagnosed with ITP, a condition where my platelet count is low without any other known disease causing it.

My liver, kidneys, and blood counts are within normal ranges.

Exclusion Criteria

I have or had blood cancer.

I have tested positive for hepatitis B.

I have a serious heart condition.

I have hepatitis C confirmed by positive tests.

Treatment Details

The study tests pirtobrutinib's tolerability and side effects in phase 1, then compares its effectiveness and safety at various doses to a placebo in phase 2. It involves oral administration of the drug and regular blood tests over up to 16 weeks for phase 1 and an additional 28 weeks for phase 2.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Pirtobrutinib Phase 2Experimental Treatment1 Intervention

Pirtobrutinib administered orally

Group II: Pirtobrutinib Phase 1Experimental Treatment1 Intervention

Pirtobrutinib administered orally

Group III: Placebo Phase 2Placebo Group1 Intervention

Placebo administered orally

Pirtobrutinib is already approved in United States for the following indications:

🇺🇸 Approved in United States as Jaypirca for: