D2212C00002 J-Phase II Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Biological: tralokinumab cohort 1
* Biological: tralokinumab cohort 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>Investigational product Tralokinumab | Biological: tralokinumab cohort 1<br>* Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor<br>|
| Experimental: High Dose<br>Investigational product Tralokinumab | Biological: tralokinumab cohort 2<br>* Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to Week 48 (treatment-emergent only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Tralokinumab Concentration Data | Serum tralokinumab concentration data will be summarized by treatment group. | 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) | 
| Immunogenecity | The incidence rate of positive serum antibodies to tralokinumab will be reported. | From baseline to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPF, Japan, Phase2, Safety, Tolerability, Idiopathic Pulmonary Fibrosis, CAT-354, Tralokinumab