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

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    85
  • sponsor
    Principia Biopharma Inc.
Updated on 21 September 2020
Investigator
Regan Burns
Primary Contact
Central Recruiting (Principia Biopharma) (4.4 mi away) Contact
+32 other location
platelet count
thrombocytopenia
autoimmune 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/L 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/L 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/L on two occasions no less than 7 days apart, within 15 days before treatment begins and a platelet count of 35,000/L 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
Treatment PRN1008
Clinical Study IdentifierNCT03395210
SponsorPrincipia Biopharma Inc.
Last Modified on21 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Immune Thrombocytopenia or Thrombocytopenic or Autoimmune disease or IDIOPATHIC THROMBOCYTOPENIC PURPURA or Idiopathic Thrombocytopenic Purpura (ITP)?
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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