D2212C00002 J-Phase II Study

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Biological: tralokinumab cohort 1; Biological: tralokinumab cohort 2; Other: Placebo

• Registration Number: NCT02036580
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2016-10-21
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	tralokinumab cohort 1	Investigational product Tralokinumab
High Dose	tralokinumab cohort 2	Investigational product Tralokinumab
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events	From baseline to Week 48 (treatment-emergent only)	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

Name	Time	Method
Serum Tralokinumab Concentration Data	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)	Serum tralokinumab concentration data will be summarized by treatment group.
Immunogenecity	From baseline to Week 48	The incidence rate of positive serum antibodies to tralokinumab will be reported.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yokohama-shi, Japan