D2212C00002 J-Phase II Study

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036580
• Other study ID #: D2212C00002
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2014
• Last updated: December 9, 2015
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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
• 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

Other:
• Placebo

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Himeji-shi
Japan	Research Site	Seto-shi
Japan	Research Site	Shibuya-ku
Japan	Research Site	Yokohama-shi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	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	Yes
Secondary	Serum tralokinumab concentration data	Serum tralokinumab concentration data will be summarized by treatment group.	From baseline to Week 48	No
Secondary	Immunogenecity	The incidence rate of positive serum antibodies to tralokinumab will be reported.	From baseline to Week 48	No