Granulomatosis with Polyangiitis (GPA MedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: INS1007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
CAS Number: 1802148-05-5
Current Sponso
Sponsors
Insmed Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who have given their signed informed consent, are male or female =18 years of age and have been diagnosed with GPA, will be eligible for enrollment in the study. Subjects must be in remission at Screening, defined as having a BVAS/WG of 0 and being symptom free for at least 30 days, or for at least 90 days if remission was induced with rituximab. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Subjects who have any other known vasculitis or have had a recent (within 4 weeks) acute systemic infection requiring medical intervention(s) or are at significant risk for infectious complications or have an abnormal renal or liver functional test result, will not be eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the PD effects of INS1007, administered once daily (QD) for 12 weeks, on novel and known biomarkers in GPA;Secondary Objective: To evaluate the effects of INS1007, administered QD for 12 weeks, on clinical disease activity as measured by Birmingham Vasculitis Activity Score for Wegener’s granulomatosis (BVAS/WG). ; Primary end point(s): Change from Baseline in exploratory PD biomarkers over the 12-week treatment period, including: • biomarker (eg, DPP1, PR3, NE, and Cat G) activities in WBCs • biomarker (eg, PR3, PR3, NE, Cat G, and PR3-ANCA) expression levels in WBCs • WBC counts, CRP levels, creatinine levels, number of peripheral-blood CD19+ B cells, and IL-6 ;Timepoint(s) of evaluation of this end point: 12-Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from Baseline in BVAS/WG over the 12 week treatment period. 2. Percentage of subjects that maintain a BVAS/WG of 0 at Week 12. 3. Percentage of subjects with a disease flare over the 12 week treatment period (a disease flare is defined as an increase in the BVAS/WG of 1 point or more). ;Timepoint(s) of evaluation of this end point: 12-Week | — |
Countries
France
Contacts
Public ContactSr Director, Regulatory affairs
Insmed Incorporated
Outcome results
None listed