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NCT02546700

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

Completed Phase 2 Last updated 6 September 2017
What this trial tests

Phase 2 trial testing Lebrikizumab in Chronic Obstructive Pulmonary Disease in 309 participants. Completed in 25 November 2016.

Timeline
30 September 2015
Primary endpoint
25 November 2016
25 November 2016

Quick facts

Lead sponsorHoffmann-La Roche
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment309
Start date30 September 2015
Primary completion25 November 2016
Estimated completion25 November 2016
Sites66 locations across Denmark, Russia, Hungary, Mexico, Poland, Argentina, Canada, Bulgaria

Drugs / interventions tested

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

  1. Role of eosinophils in airway inflammation of chronic obstructive pulmonary disease.
    Tashkin DP, Wechsler ME. · · 2018 · cited 114× · PMID 29403271 · DOI 10.2147/copd.s152291
  2. Mitochondrial network dynamics in pulmonary disease: Bridging the gap between inflammation, oxidative stress, and bioenergetics.
    Pokharel MD, Garcia-Flores A, Marciano D, Franco MC, et al · · 2024 · cited 73× · PMID 38295575 · DOI 10.1016/j.redox.2024.103049
  3. Mechanisms, Pathophysiology and Currently Proposed Treatments of Chronic Obstructive Pulmonary Disease.
    Rodrigues SO, Cunha CMCD, Soares GMV, Silva PL, et al · · 2021 · cited 61× · PMID 34681202 · DOI 10.3390/ph14100979
  4. Novel Anti-Inflammatory Approaches to COPD.
    Cazzola M, Hanania NA, Page CP, Matera MG. · · 2023 · cited 42× · PMID 37408603 · DOI 10.2147/copd.s419056
  5. Emerging pharmaceutical therapies for COPD.
    Lakshmi SP, Reddy AT, Reddy RC. · · 2017 · cited 35× · PMID 28790817 · DOI 10.2147/copd.s121416
  6. Targeted therapy in eosinophilic chronic obstructive pulmonary disease.
    Fieldes M, Bourguignon C, Assou S, Nasri A, et al · · 2021 · cited 30× · PMID 33855061 · DOI 10.1183/23120541.00437-2020
  7. Eosinophilic Airway Diseases: From Pathophysiological Mechanisms to Clinical Practice.
    Mormile M, Mormile I, Fuschillo S, Rossi FW, et al · · 2023 · cited 24× · PMID 37108417 · DOI 10.3390/ijms24087254
  8. An Overview of the Safety and Efficacy of Monoclonal Antibodies for the Chronic Obstructive Pulmonary Disease.
    Cazzola M, Ora J, Cavalli F, Rogliani P, et al · · 2021 · cited 22× · PMID 34475751 · DOI 10.2147/btt.s295409

Verify or expand the search:

Other trials of Lebrikizumab

Trials testing the same drug.

Other recruiting trials for Chronic Obstructive Pulmonary Disease

Currently open trials in the same condition.

Other Hoffmann-La Roche trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02546700.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing