D2212C00002 J-Phase II Study

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Biological: tralokinumab cohort 2; Other: Placebo; Biological: tralokinumab cohort 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02036580

D2212C00002

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups, including a placebo group

Low Dose

Experimental group

Description:

Investigational product Tralokinumab

Treatment:

Biological: tralokinumab cohort 1

High Dose

Experimental group

Description:

Investigational product Tralokinumab

Treatment:

Biological: tralokinumab cohort 2

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo