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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Principia Biopharma, a Sanofi Company

Criteria

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