D2212C00002 J-Phase II Study

• ClinicalTrials.gov Identifier: NCT02036580
• Recruitment Status: Completed
• First Posted: January 15, 2014
• Results First Posted: February 23, 2017
• Last Update Posted: February 23, 2017
• Sponsor: AstraZeneca
• Collaborator: MedImmune LLC
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Pulmonary Fibrosis	Biological: tralokinumab cohort 1; Biological: tralokinumab cohort 2; Other: Placebo	Phase 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: January 2014
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: Placebo; Placebo	Other: Placebo

Outcome Measures

Primary Outcome Measures :

1. Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events [ Time Frame: 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 :

1. Serum Tralokinumab Concentration Data [ 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) ]
   Serum tralokinumab concentration data will be summarized by treatment group.
2. Immunogenecity [ Time Frame: From baseline to Week 48 ]
   The incidence rate of positive serum antibodies to tralokinumab will be reported.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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, Japan

Sponsors and Collaborators

AstraZeneca

MedImmune LLC

Investigators

• Study Director: Joseph M Parker, MD; MedImmune LLC

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02036580
• Other Study ID Numbers: D2212C00002
• First Posted: January 15, 2014
• Results First Posted: February 23, 2017
• Last Update Posted: February 23, 2017
• Last Verified: January 2017

Keywords provided by AstraZeneca:

Japan; Phase2; Safety; Tolerability; Idiopathic Pulmonary Fibrosis; IPF; CAT-354; Tralokinumab

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs