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BTK Inhibitor

Rilzabrutinib for Immune Thrombocytopenia

Phase 2

Waitlist Available

Research Sponsored by Principia Biopharma, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Immune-related ITP (both primary and secondary)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks of treatment, long term extension and 4 weeks of follow up post last dose]

Awards & highlights

Study Summary

This trial is testing a new drug, PRN1008, for people with ITP who have tried other treatments that haven't worked. The dosage is still being determined, but right now it's 400 mg twice daily.

Who is the study for?

Adults aged 18 to 80 with immune-related ITP, a condition where the immune system destroys platelets, are eligible for this trial. Participants must have a low platelet count and not respond well to other treatments. Those with drug or alcohol abuse, organ transplants, HIV, hepatitis B/C, or who are pregnant/breastfeeding cannot join.Check my eligibility

What is being tested?

The study is testing Rilzabrutinib (PRN1008), specifically at a dose of 400 mg twice daily for adults with refractory or relapsed ITP after completing an initial dose-finding phase. The goal is to see if it can safely increase platelet counts in these patients.See study design

What are the potential side effects?

While specific side effects for Rilzabrutinib in this trial aren't listed here, common ones may include digestive issues, headaches, fatigue and potential risks associated with lowering the body's immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have immune-related ITP.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks of treatment, long term extension and 4 weeks of follow up post last dose]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks of treatment, long term extension and 4 weeks of follow up post last dose]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks of treatment, long term extension and 4 weeks of follow up post last dose] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A and B: Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)

Part A: Consecutive Increased Platelet Counts (Efficacy Outcome Measure)

Part B: Sustained Increase in Platelet Counts (Efficacy Outcome Measure)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rilzabrutinib (PRN1008) DailyExperimental Treatment1 Intervention

Part A approximately 60 patients: Up to 24 weeks open-label treatment with PRN1008 400mg BID; safety and dose evaluation. Patients who respond to PRN1008 per protocol may enter a long-term extension. Part B approximately 25 patients: Up to 24 weeks open-label treatment with PRN1008 400mg BID; safety and dose evaluation. Patients who respond to PRN1008 per protocol may enter a long-term extension

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rilzabrutinib

2021

Completed Phase 2

~320

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Principia Biopharma, a Sanofi CompanyLead Sponsor

7 Previous Clinical Trials

502 Total Patients Enrolled

Olga Bandman, MDStudy DirectorPrincipia Biopharma

1 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

PRN1008 (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03395210 — Phase 2

Thrombocytopenic Purpura Research Study Groups: Rilzabrutinib (PRN1008) Daily

Thrombocytopenic Purpura Clinical Trial 2023: PRN1008 Highlights & Side Effects. Trial Name: NCT03395210 — Phase 2

PRN1008 (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03395210 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this trial's implementation?

"This research is enrolling patients from 13 different sites, including Investigational Site Number 1161 in Toronto, Canada; 1098 in Seattle, Washington; and the New york City location (1097)."

Answered by AI

Is there an age restriction limiting enrollment in this research trial?

"Adherence to the eligibility criteria of this research protocol mandates that participants be aged at least 18 and not older than 80."

Answered by AI

Are there openings available for potential participants in this study?

"Per the data on clinicaltrials.gov, this medical study is not presently recruiting any participants. Established in March 2018 and most recently updated November 2022, this trial is temporarily on hiatus; however, 143 other trials are seeking patients at present."

Answered by AI

Is there the possibility for me to participate in this scientific experiment?

"The study is seeking 81 individuals that have been diagnosed with idiopathic thrombocytopenic purpura and are between 18 to 80 years old. To qualify, candidates should be either male or female within the afore-mentioned age range."

Answered by AI