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Trial record 3 of 11 for:    medimmune tralokinumab

D2212C00002 J-Phase II Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036580
First Posted: January 15, 2014
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Idiopathic Pulmonary Fibrosis Biological: tralokinumab cohort 1 Biological: tralokinumab cohort 2 Other: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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.

  • Immunogenecity [ Time Frame: From baseline to Week 48 ]
    The incidence rate of positive serum antibodies to tralokinumab will be reported.


Enrollment: 37
Study Start Date: January 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036580


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     History of Changes
Other Study ID Numbers: D2212C00002
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: October 21, 2016
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:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs