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Trial record 1 of 1 for:    PRN 1008-010 ITP
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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 : December 10, 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

Locations
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United States, Illinois
Central Recruiting (Principia Biopharma) Recruiting
Peoria, Illinois, United States, 61615
United States, Maryland
Central Recruiting (Principia Biopharma) Recruiting
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Central Recruiting (Principia Biopharma) Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Central Recruiting (Principia Biopharma) Recruiting
Midland, Michigan, United States, 48670
United States, New York
Central Recruiting by Principia Biopharma Recruiting
New York, New York, United States, 10065
United States, North Carolina
Central Recruiting (Principia Biopharma) Recruiting
Greenville, North Carolina, United States, 27834
United States, Washington
Central Recruiting (Principia Biopharma) Recruiting
Seattle, Washington, United States, 98109
Australia, Australia Capital Territory
Central Recruting (Principia Biopharma) Recruiting
Garran, Australia Capital Territory, Australia
Australia, New South Wales
Central Recruiting (Principia Biopharma) Recruiting
Concord, New South Wales, Australia, 2139
Australia, Queensland
Central Recruiting (Principia Biopharma) Recruiting
Brisbane, Queensland, Australia, 4102
Australia, Victoria
Central Recruiting (Principia Biopharma) Recruiting
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Central Recruiting (Principia Biopharma) Recruiting
Nedlands, Western Australia, Australia, 6009
Bulgaria
Central Recruiting (Principia Biopharma) Recruiting
Pleven, Bulgaria, 5800
Central Recruiting (Principia Biopharma) Recruiting
Sofia, Bulgaria, 1233
Central Recruiting (Principia Biopharma) Recruiting
Varna, Bulgaria, 9010
Canada, Ontario
Central Recruiting (Principia Biopharma) Recruiting
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Central Recruting (Principia Biopharma) Recruiting
Montréal, Quebec, Canada
Czechia
Central Recruiting (Principia Biopharma) Recruiting
Brno, Czechia, 625 00
Central Recruiting (Principia Biopharma) Recruiting
Hradec Králové, Czechia, 500 05
Central Recruiting (Principia Biopharma) Recruiting
Ostrava, Czechia, 70852
Central Recruiting (Principia Biopharma) Recruiting
Prague, Czechia, 128 08
Netherlands
Central Recruiting (Principia Biopharma) Recruiting
the Hague, South Holland, Netherlands, 2545CH
Central Recruiting (Principia Biopharma) Recruiting
Rotterdam, Netherlands, 3015 GD
Norway
Central Recruiting (Principia Biopharma) Recruiting
Bergen, Norway
Central Recruiting (Principia Biopharma) Recruiting
Grålum, Norway, 1714
United Kingdom
Central Recruiting (Principia Biopharma) Recruiting
London, England, United Kingdom
Central Recruiting (Principia Biopharma) Recruiting
Leicester, United Kingdom, LE1 5WW
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    
Other Study ID Numbers: PRN1008-010
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 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