D2212C00002 J-Phase II Study

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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: Placebo; Biological: tralokinumab cohort 1; Biological: tralokinumab cohort 2

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka-shi, Japan
    • Research Site
  • Himeji-shi, Japan
    • Research Site
  • Seto-shi, Japan
    • Research Site
  • Shibuya-ku, Japan
    • Research Site
  • Yokohama-shi, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo
Experimental: Low Dose; Investigational product Tralokinumab	Biological: 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
Experimental: High Dose; Investigational product Tralokinumab	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: MedImmune LLC
• Investigators: Study Director: Joseph M Parker, MD, MedImmune LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Japan; Idiopathic Pulmonary Fibrosis; IPF; Tralokinumab; CAT-354; Phase2
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: D2212C00002