A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT02546700 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2017-09-06

No results posted yet for this study

Summary

Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.

Conditions

Interventions

DRUG

Lebrikizumab

Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.

DRUG

Placebo

Matching placebo will be administered subcutaneously once in 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
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-11-25
Completion
2016-11-25

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Denmark
  • Hungary
  • Mexico
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

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 NCT02546700 on ClinicalTrials.gov