Clinical trial NCT02036580: D2212C00002 J-Phase II Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Japan
Phase2
Safety
Tolerability
Idiopathic Pulmonary Fibrosis
IPF
CAT-354
Tralokinumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune LLC
First posted: 2014-01-15
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
timeFrame: From baseline to Week 48 (treatment-emergent only)
Secondary outcomes:
measure: Serum Tralokinumab Concentration Data
timeFrame: 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)
measure: Immunogenecity
timeFrame: From baseline to Week 48
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Himeji-shi
country: Japan
facility: Research Site
city: Seto-shi
country: Japan
facility: Research Site
city: Shibuya-ku
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: Joseph M Parker, MD
role: STUDY_DIRECTOR
References: