A Study of PRN1008 in Adult Patients With Immune Thrombocytopenia (ITP)

  • STATUS
    Recruiting
  • End date
    Mar 19, 2024
  • participants needed
    85
  • sponsor
    Principia Biopharma, a Sanofi Company
Updated on 13 May 2022
platelet count
thrombocytopenia

Summary

This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study has been completed. Part B treatment dose is 400 mg twice daily.

Description

This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in approximately 60 patients in Part A and approximately 25 patients in Part B.

Part A enrolls patients with ITP who are refractory or relapsed with no available and approved therapeutic options. Eligible patients have a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. In the dose-finding part of the study, each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term-extension.

Part B of the study will include approximately 25 patients with ITP who have relapsed or have an insufficient response to prior therapies. Eligible patients will have a platelet count <30,000/µL on two occasions no less than 7 days apart, within 15 days before treatment begins and a platelet count of ≤35,000/µL on Study Day 1 (SD1). The study consists of a 28-day screening period, 24-week active treatment period, and a long-term extension. After the last dose of PRN1008 there will be a 4-week safety follow-up period.

Details
Condition Immune Thrombocytopenia, Immune Thrombocytopenic Purpura
Treatment PRN1008
Clinical Study IdentifierNCT03395210
SponsorPrincipia Biopharma, a Sanofi Company
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients, aged 18 to 80 years old
Immune-related ITP (both primary and secondary)

Exclusion Criteria

Pregnant or lactating women
Current drug or alcohol abuse
History of solid organ transplant
Positive screening for HIV, hepatitis B, or hepatitis C
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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