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

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ClinicalTrials.gov Identifier: NCT03395210
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Principia Biopharma Inc.

Brief Summary:
This is an 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Drug: PRN1008 Phase 1 Phase 2

Detailed Description:
This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 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 active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: PRN1008 Daily
Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks. Patients who respond to PRN1008 per protocol may enter a long term extension.
Drug: PRN1008
BTK inhibitor




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure) [ Time Frame: 24 weeks of treatment, long term extension and 4 weeks of follow up ]
    The incidence, severity and relationship of TEAEs during the treatment period and TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.

  2. Consecutive Increased Platelet Counts (Efficacy Outcome Measure) [ Time Frame: 24 Weeks ]
    Proportion of subjects able to achieve two or more consecutive platelet counts of ≥ 50,000/μL AND an increase of platelet count of ≥20,000/μL from baseline, without the use of rescue medication



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395210


Contacts
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Contact: Regan Burns 1-833-477-6700 clinicaltrials@principiabio.com

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Sponsors and Collaborators
Principia Biopharma Inc.
Investigators
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Study Director: Olga Bandman, MD Principia Biopharma

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Responsible Party: Principia Biopharma Inc.
ClinicalTrials.gov Identifier: NCT03395210     History of Changes
Other Study ID Numbers: PRN1008-010
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases