NCT02036580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 13, 2014

Results QC Date

October 21, 2016

Last Update Submit

January 4, 2017

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

JapanPhase2SafetyTolerabilityIdiopathic Pulmonary FibrosisIPFCAT-354Tralokinumab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • Immunogenecity

    From baseline to Week 48

Study Arms (3)

Low Dose

EXPERIMENTAL

Investigational product Tralokinumab

Biological: tralokinumab cohort 1

High Dose

EXPERIMENTAL

Investigational product Tralokinumab

Biological: tralokinumab cohort 2

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

tralokinumab cohort 1BIOLOGICAL

Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor

Low Dose
tralokinumab cohort 2BIOLOGICAL

Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor

High Dose
PlaceboOTHER
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • FVC ≥ 50% and ≤ 90% predicted normal
  • 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
  • Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Fukuoka, Japan

Location

Research Site

Himeji-shi, Japan

Location

Research Site

Seto-shi, Japan

Location

Research Site

Shibuya-ku, Japan

Location

Research Site

Yokohama, Japan

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Clinical Study Information Center
Organization
AstraZeneca
information.center@astrazeneca.com
1-877-240-9479

Study Officials

  • Joseph M Parker, MD

    MedImmune LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 23, 2017

Results First Posted

February 23, 2017

Record last verified: 2017-01

Locations

JP(5)