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
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
-
Matching placebo will be administered subcutaneously once in every 4 weeks.
Sponsors & Collaborators
- lead INDUSTRY
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
-
Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler
NCT04027439 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
NCT01009424 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
NCT04751487 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01013142 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
NCT01033487 ·Status: COMPLETED ·Phase: PHASE2
-
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
NCT07177339 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
NCT04701983 ·Status: COMPLETED ·Phase: PHASE3
-
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01867762 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT00665600 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT02294734 ·Status: COMPLETED ·Phase: PHASE2
-
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
NCT02366637 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT07292714 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
NCT00219622 ·Status: COMPLETED ·Phase: PHASE2
-
Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT03546907 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions
NCT07052396 ·Status: RECRUITING
-
Study to Evaluate Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01108913 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
NCT06491043 ·Status: RECRUITING ·Phase: PHASE2
-
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
NCT03930732 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
NCT07190222 ·Status: RECRUITING ·Phase: PHASE3
-
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
NCT02272634 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
NCT04882124 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
NCT02662582 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT05595642 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00676052 ·Status: COMPLETED ·Phase: PHASE2
-
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
NCT00376714 ·Status: COMPLETED ·Phase: PHASE2