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D2212C00002 J-Phase II Study

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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:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE January 15, 2014
Results First Submitted Date  ICMJE October 21, 2016
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
Safety and tolerability [ Time Frame: From baseline to Week 48 ]
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.
Change History Complete list of historical versions of study NCT02036580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
  • Serum Tralokinumab Concentration Data [ Time Frame: From baseline to 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D2212C00002 J-Phase II Study
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • 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
  • 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
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Low Dose
    Investigational product Tralokinumab
    Intervention: Biological: tralokinumab cohort 1
  • Experimental: High Dose
    Investigational product Tralokinumab
    Intervention: Biological: tralokinumab cohort 2
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2015)
37
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2014)
20
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02036580
Other Study ID Numbers  ICMJE D2212C00002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE MedImmune LLC
Investigators  ICMJE
Study Director: Joseph M Parker, MD MedImmune LLC
PRS Account AstraZeneca
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP