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NCT02546700

PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a History of Exacerbations

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

309

Start Date

2015-09-17

Completion Date

2016-11-25

Last Updated

2026-09-10

Healthy Volunteers

Conditions

Chronic Obstructive Pulmonary Disease

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.

Inclusion Criteria: * Documented history of COPD greater than or equal to (\>/=) 12 months prior to Visit 1 * 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 severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to lebrikizumab injection * 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

Locations (63)

Achieve Clinical Research, LLC

Birmingham, Alabama, 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

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

McMaster University Medical Centre

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Inspiration Research

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 Rendel?intézet; 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, Durango, Mexico

Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

Santa Cecilia, Jalisco, Mexico

Centro Respiratorio de México

México, Mexico CITY (federal District), Mexico

Oaxaca Site Management Organization

Oaxaca City, Oaxaca, 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 Spó?ka Jawna

Lublin, Poland

Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

Ruda ?l?ska, Poland

NZOZ Lekarze Specjalisci

Wroclaw, Poland

SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

Saint Petersburg, Sankt-Peterburg, Russia

St. Petersburg State Medical University n.a. I.P. Pavlov

Saint Petersburg, Sankt-Peterburg, Russia

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

Siberian State Medical University

Tomsk, Russia

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)