NCT02036580

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

Completed Phase 2 Results posted Last updated 4 January 2017

What this trial tests

Phase 2 trial testing tralokinumab cohort 1 in Idiopathic Pulmonary Fibrosis in 37 participants. Completed in 1 November 2015.

Timeline

1 January 2014

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	37
Start date	1 January 2014
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	5 locations across Japan

Drugs / interventions tested

• tralokinumab cohort 1 — full drug profile →
• tralokinumab cohort 2
• Placebo

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

AstraZeneca — full company profile →

Who can join

50 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging therapies for idiopathic pulmonary fibrosis, a progressive age-related disease.
   Mora AL, Rojas M, Pardo A, Selman M. · · 2017 · cited 99× · PMID 29081515 · DOI 10.1038/nrd.2017.225
2. Regulatory Immune Cells in Idiopathic Pulmonary Fibrosis: Friends or Foes?
   van Geffen C, Deißler A, Quante M, Renz H, et al · · 2021 · cited 65× · PMID 33995390 · DOI 10.3389/fimmu.2021.663203
3. Lung Fibrosis and Fibrosis in the Lungs: Is It All about Myofibroblasts?
   Ortiz-Zapater E, Signes-Costa J, Montero P, Roger I. · · 2022 · cited 62× · PMID 35740444 · DOI 10.3390/biomedicines10061423
4. The oncogenic landscape of the idiopathic pulmonary fibrosis: a narrative review.
   Stella GM, D'Agnano V, Piloni D, Saracino L, et al · · 2022 · cited 21× · PMID 35399571 · DOI 10.21037/tlcr-21-880
5. The Immune Microenvironment: New Therapeutic Implications in Organ Fibrosis.
   Chen X, Wu C, Tang F, Zhou J, et al · · 2025 · cited 3× · PMID 40391706 · DOI 10.1002/advs.202505067
6. Promising new treatment targets in patients with fibrosing lung disorders.
   Sterclova M, Vasakova M. · · 2014 · cited 3× · PMID 25405190 · DOI 10.12998/wjcc.v2.i11.668