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A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT01872689 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2018-08-24

Study results available
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Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.

Conditions

Interventions

DRUG

Lebrikizumab

Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.

DRUG

Pirfenidone

Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.

DRUG

Placebo

Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-13
Primary Completion
2017-07-28
Completion
2017-11-06

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01872689 on ClinicalTrials.gov