A Study to Assess the pharmacokinetics and pharmacodynamics of INS1007 Administered Once Daily in Patients with Granulomatosis with Polyangiitis (GPA)

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2018-003903-21-FR
• Date of registration: 19/02/2019
• Prospective Registration: Yes
• Primary sponsor: Insmed Incorporated
• Public title: A Study to Assess the pharmacokinetics and pharmacodynamics of INS1007 Administered Once Daily in Patients with Granulomatosis with Polyangiitis (GPA)
• Scientific title: A Randomized, Single-Blind Study to Evaluate the Pharmacokinetics (PK), and Pharmacodynamics (PD) of INS1007 Administered for 12 Weeks in Subjects with Granulomatosis with Polyangiitis (GPA)
• Date of first enrolment: 04/06/2019
• Target sample size: 16
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003903-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: yes; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Different dosage of the same product: 10mg+Placebo or 40 mg; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: Sr Director, Regulatory affairs
• Affiliation: Insmed Incorporated

• Name: Sr Director, Regulatory affairs
• Affiliation: Insmed Incorporated

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Granulomatosis with Polyangiitis (GPA
MedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders

Intervention(s)

Product Name: INS1007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
CAS Number: 1802148-05-5
Current Sponsor code: INS1007
Other descriptive name: AZD7986
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: INS1007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
CAS Number: 1802148-05-5
Current Sponsor code: INS1007
Other descriptive name: AZD7986
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: INS1007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
CAS Number: 1802148-05-5
Current Sponsor code: INS1007
Other descriptive name: AZD7986
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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).

Timepoint(s) of evaluation of this end point: 12-Week

Secondary Outcome(s)

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

Secondary ID(s)

INS1007-202

Source(s) of Monetary Support

Insmed Incorporated

Ethics review

Status: Approved
Approval date:
Contact: