Phase 2
Completed N=20
D2212C00002 J-Phase II Study
Source: ClinicalTrials.gov NCT02036580 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Feb 2017
Primary outcomePrimary: Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events — 8; 7; 2; 1 Patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events |
8; 7; 2; 1; 2; 0 | — |
| SECONDARY Serum Tralokinumab Concentration Data |
149; 313; 33.9; 76.1; 55.1; 75.7 | — |
| SECONDARY Immunogenecity |
1; 0; 0; 0; 0; 0 | — |
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
- 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
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
Data sourced from ClinicalTrials.gov (NCT02036580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.