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A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

NCT01629667 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2017-05-15

Study results available
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Summary

To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.

Conditions

Interventions

BIOLOGICAL

Tralokinumab

Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.

BIOLOGICAL

Tralokinumab

Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.

OTHER

Placebo

Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Joseph Parker, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-05-31
Completion
2016-01-31

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • Peru
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629667 on ClinicalTrials.gov