A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT02546700
Last Updated: 2017-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
309 participants
INTERVENTIONAL
2015-09-30
2016-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
NCT06154837
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
NCT00783406
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
NCT00263874
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
NCT01448850
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01227278
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lebrikizumab: Biomarker-high
Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.
Lebrikizumab
Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
Lebrikizumab: Biomarker-low
Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.
Lebrikizumab
Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
Placebo: Biomarker-high
Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.
Placebo
Matching placebo will be administered subcutaneously once in every 4 weeks.
Placebo: Biomarker-low
Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.
Placebo
Matching placebo will be administered subcutaneously once in every 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lebrikizumab
Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
Placebo
Matching placebo will be administered subcutaneously once in every 4 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post-bronchodilator FEV1/FVC less than (\<) 0.70 at Visit 1 or 2
* Post bronchodilator FEV1 \<80% predicted at Visit 1 or 2
* Documented history of one or more acute COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1
* Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking \>/=10 pack-years (20 cigarettes/day for 10 years)
* On inhaled corticosteroids (ICS) therapy for \>/=6 months prior to Visit 1
* On an eligible bronchodilator medication for \>/=6 months prior to Visit 1
* Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray prior to Visit 2 that confirms absence of clinically significant lung disease besides COPD
* Demonstrated adherence with background COPD inhaler medication during screening period
* For female participants of childbearing age, use of single or combined contraceptive methods for the duration of the study
Exclusion Criteria
* History of clinically significant pulmonary disease other than COPD
* Diagnosis of alpha-1-antitrypsin deficiency
* Lung volume reduction surgery or procedure within 12 months prior to Visit 1
* Supplemental oxygen requirement \>2 liters/minute (L/min) at rest or with exertion
* Current diagnosis of asthma
* Participants participating in, or scheduled for, an intensive COPD rehabilitation program
* Maintenance oral corticosteroid therapy
* Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during screen period
* Unstable ischemic heart disease or other relevant cardiovascular disorders
* Use of an immunomodulatory or immunosuppressive therapy including monoclonal antibodies (includes anti-interleukin-13 (IL) or anti-IL-4/IL-13 therapy)
* Body weight \<40 kg
* Any infection that resulted in hospital admission for \>/= 24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
* Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
* Active parasitic or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
* Received a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening
* Active tuberculosis requiring treatment within 12 months prior to Visit 1
* Human immunodeficiency virus (HIV) or other known immunodeficiency
* Hepatitis or known liver cirrhosis
* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ATL), or total bilirubin elevation \>/=2.0 x upper limit of normal (ULN) during screening
* Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests
* History of alcohol or drug abuse
* Pregnant or lactating
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC
Peoria, Arizona, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Palmtree Clinical research Inc
Palm Springs, California, United States
Finlay Medical Research
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Southeast Regional Res Group
Savannah, Georgia, United States
Centex Studies
Lake Charles, Louisiana, United States
The Clinical Research Ctr
St Louis, Missouri, United States
Comprehensive Clinical Research Inc.
Berlin, New Jersey, United States
ISA Clinical Research
Jamaica, New York, United States
Gastonia Pharmaceutical Research
Gastonia, North Carolina, United States
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, United States
Piedmont Research Partners LLC
Old Point Station, South Carolina, United States
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States
Baylor College of Medicine; Ben Taub Hospital- Guntupalli
Houston, Texas, United States
Centex Studies
Houston, Texas, United States
Western Washington Medical Group
Everett, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
MultiCare Health Center of Washington
Tacoma, Washington, United States
Centro Médico Dra de Salvo
Buenos Aires, , Argentina
Instituto Ave Pulmo
Mar del Plata, , Argentina
Centro Respiratorio Quilmes
Quilmes, , Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, , Argentina
Instituto Del Buen Aire
Santa Fe, , Argentina
Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology
Rousse, , Bulgaria
MHC - Sofia, EOOD
Sofia, , Bulgaria
Fifth MHAT - Sofia EAD
Sofia, , Bulgaria
National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, , Bulgaria
Medical Center Tara OOD
Veliko Tarnovo, , Bulgaria
Concordia Hospital,Repiratory Research
Winnipeg, Manitoba, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Inspiration Research Limited
Toronto, Ontario, Canada
Hvidovre Hospital, Lungemedicinsk Afdeling
Hvidovre, , Denmark
Lungemedicinsk afd. L, Bispebjerg Hospital
København NV, , Denmark
Odense Universitetshospital, Lungemedicinsk Forskningsenhed
Odense C, , Denmark
Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
Balassagyarmat, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés
Komárom, , Hungary
Matrai Állami Gyógyintézet ; Bronchológia
Mátraháza, , Hungary
CRU Hungary Kft
Miskolc, , Hungary
Mohacsi Korhaz
Mohács, , Hungary
Farmakontroll Bt.
Százhalombatta, , Hungary
Markusovszky Egyetemi Oktatokorhaz; Tudogondozo
Szombathely, , Hungary
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, , Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, , Mexico
Centro Respiratorio de México
México, , Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Centro Integral Médico SJR SC
Querétaro, , Mexico
Mazowieckie Centrum Badan Klinicznych S.C.
Grodzisk Mazowiecki, , Poland
Poradnia Pulmonologiczna dla Doroslych
Lódz, , Poland
MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spółka Jawna
Lublin, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
Ruda Śląska, , Poland
NZOZ Lekarze Specjalisci
Wroclaw, , Poland
FSI Scientific Research Inst
Moscow, , Russia
Central Clinical Hospital #1 of RZhD JCS
Moscow, , Russia
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, , Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
LLC Reafan
Novosibirsk, , Russia
LLC Medical Center "Alliance-Biomedical - Russian Group"
Saint Petersburg, , Russia
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, , Russia
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, , Russia
Siberian State Medical University
Tomsk, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-001122-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WB29804
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.