|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02036580 |
|
Date of registration:
|
13/01/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
D2212C00002 J-Phase II Study
|
|
Scientific 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 |
|
Date of first enrolment:
|
January 2014 |
|
Target sample size:
|
37 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02036580 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Joseph M Parker, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MedImmune LLC |
| | |
|
Key inclusion & exclusion 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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Pulmonary Fibrosis
|
|
Intervention(s)
|
|
Biological: tralokinumab cohort 1
|
|
Other: Placebo
|
|
Biological: tralokinumab cohort 2
|
|
Primary Outcome(s)
|
|
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
[Time Frame: From baseline to Week 48 (treatment-emergent only)]
|
|
Secondary Outcome(s)
|
|
Immunogenecity
[Time Frame: From baseline to Week 48]
|
|
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)]
|
|
Secondary ID(s)
|
|
D2212C00002
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|