D2212C00002 J-Phase II Study

Phase 2CompletedNCT02036580

AstraZeneca37 enrolled

Overview

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

tralokinumab cohort 1BIOLOGICAL

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

tralokinumab cohort 2BIOLOGICAL

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

PlaceboOTHER

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (5)

Research Site

Fukuoka, Japan

Research Site

Himeji-shi, Japan

Research Site

Seto-shi, Japan

Research Site

Shibuya-ku, Japan

Research Site

Yokohama, Japan

Outcomes

Primary Outcomes

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.

Time frame: From baseline to Week 48 (treatment-emergent only)

Secondary Outcomes

Serum Tralokinumab Concentration Data

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)

Immunogenecity

The incidence rate of positive serum antibodies to tralokinumab will be reported.

Time frame: From baseline to Week 48

Data from ClinicalTrials.gov

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