D2212C00002 J-Phase II Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

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.

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low Dose

Investigational product Tralokinumab

Group Type EXPERIMENTAL

tralokinumab cohort 1

Intervention Type BIOLOGICAL

Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor

High Dose

Investigational product Tralokinumab

Group Type EXPERIMENTAL

tralokinumab cohort 2

Intervention Type BIOLOGICAL

Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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tralokinumab cohort 1

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

tralokinumab cohort 2

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

Placebo

Intervention Type OTHER

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

1. FVC ≥ 50% and ≤ 90% predicted normal
2. 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
3. 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No