Back to resultsD2212C00002 J-Phase II Study
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
tralokinumab cohort 1
tralokinumab cohort 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Japan, Phase2, Safety, Tolerability, Idiopathic Pulmonary Fibrosis, IPF, CAT-354, Tralokinumab
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
Mild to moderate IPF to include all of the following at Visit 1
- FVC ≥ 50% and ≤ 90% predicted normal
- Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest
- Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal
Exclusion Criteria:
- History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
- Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
- A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1
- A suspected IPF exacerbation during the screening period
- A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator)
- The extent of emphysema on the HRCT is greater than the extent of fibrosis
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Low Dose
High Dose
Placebo
Arm Description
Investigational product Tralokinumab
Investigational product Tralokinumab
Placebo
Outcomes
Primary Outcome Measures
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.
Secondary Outcome Measures
Serum Tralokinumab Concentration Data
Serum tralokinumab concentration data will be summarized by treatment group.
Immunogenecity
The incidence rate of positive serum antibodies to tralokinumab will be reported.
Full Information
NCT ID
NCT02036580
First Posted
January 13, 2014
Last Updated
January 4, 2017
Sponsor
AstraZeneca
Collaborators
MedImmune LLC
1. Study Identification
Unique Protocol Identification Number
NCT02036580
Brief Title
D2212C00002 J-Phase II Study
Official Title
A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
MedImmune LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.
Detailed Description
This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50 years with mild to moderate Idiopathic Pulmonary Fibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Japan, Phase2, Safety, Tolerability, Idiopathic Pulmonary Fibrosis, IPF, CAT-354, Tralokinumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Investigational product Tralokinumab
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Investigational product Tralokinumab
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
tralokinumab cohort 1
Intervention Description
Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
Intervention Type
Biological
Intervention Name(s)
tralokinumab cohort 2
Intervention Description
Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
Description
Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.
Time Frame
From baseline to Week 48 (treatment-emergent only)
Secondary Outcome Measure Information:
Title
Serum Tralokinumab Concentration Data
Description
Serum tralokinumab concentration data will be summarized by treatment group.
Time Frame
From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48)
Title
Immunogenecity
Description
The incidence rate of positive serum antibodies to tralokinumab will be reported.
Time Frame
From baseline to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
Mild to moderate IPF to include all of the following at Visit 1
FVC ≥ 50% and ≤ 90% predicted normal
Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest
Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal
Exclusion Criteria:
History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1
A suspected IPF exacerbation during the screening period
A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator)
The extent of emphysema on the HRCT is greater than the extent of fibrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Parker, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Fukuoka-shi
Country
Japan
Facility Name
Research Site
City
Himeji-shi
Country
Japan
Facility Name
Research Site
City
Seto-shi
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
D2212C00002 J-Phase II Study
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