A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02546700
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab: Biomarker-high Lebrikizumab Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high. Lebrikizumab: Biomarker-low Lebrikizumab Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low. Placebo: Biomarker-high Placebo Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high. Placebo: Biomarker-low Placebo Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events And Serious Adverse Events Baseline up to Week 36 Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin) Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24 Plasma Decay Half-Life (t1/2) Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 8, 12, 16, 20; at Weeks 24, 28, and 36 Rate of Moderate or Severe COPD Exacerbation Baseline up to Week 24 Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24 Baseline, Week 24 Time to First COPD Exacerbation Baseline up to Week 24 Change From Baseline in COPD Symptoms as Measured by the Overall Score of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) at Week 24 Baseline, Week 24 Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24 Baseline, Week 24 Change From Baseline in Cough and Sputum as Measured by the Cough and Sputum Domain Score of the EXACT at Week 24 Baseline, Week 24 Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24 Baseline, Week 24 Change From Baseline in Health-related Quality of Life as Assessed by the Overall Score of the Saint George's Respiratory Questionnaire for COPD (SGRQ-C) at Week 24 Baseline, Week 24 Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab Baseline up to Week 36
Trial Locations
- Locations (65)
Centex Studies
🇺🇸Houston, Texas, United States
Comprehensive Clinical Research Inc.
🇺🇸Berlin, New Jersey, United States
Clinical Research Inst. of Southern Oregon, Pc
🇺🇸Medford, Oregon, United States
Baylor College of Medicine; Ben Taub Hospital- Guntupalli
🇺🇸Houston, Texas, United States
Inspiration Research Limited
🇨🇦Toronto, Ontario, Canada
NZOZ Lekarze Specjalisci
🇵🇱Wroclaw, Poland
Centro Integral Médico SJR SC
🇲🇽Querétaro, Mexico
Centro de Investigacion y Atencion Integral Durango CIAID
🇲🇽Durango, Mexico
Centro Respiratorio de México
🇲🇽Mexico, Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
🇲🇽Guadalajara, Mexico
Hvidovre Hospital, Lungemedicinsk Afdeling
🇩🇰Hvidovre, Denmark
Lungemedicinsk afd. L, Bispebjerg Hospital
🇩🇰København NV, Denmark
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Finlay Medical Research
🇺🇸Miami, Florida, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
The Clinical Research Ctr
🇺🇸Saint Louis, Missouri, United States
Gastonia Pharmaceutical Research
🇺🇸Gastonia, North Carolina, United States
Medical Center Tara OOD
🇧🇬Veliko Tarnovo, Bulgaria
Centro Médico Dra de Salvo
🇦🇷Buenos Aires, Argentina
Centro Respiratorio Quilmes
🇦🇷Quilmes, Argentina
Western Washington Medical Group
🇺🇸Everett, Washington, United States
Petz Aladar Megyei Oktato Korhaz
🇭🇺Gyor, Hungary
Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology
🇧🇬Ruse, Bulgaria
MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spółka Jawna
🇵🇱Lublin, Poland
Odense Universitetshospital, Lungemedicinsk Forskningsenhed
🇩🇰Odense C, Denmark
FSI Scientific Research Inst
🇷🇺Moscow, Russian Federation
MHC - Sofia, EOOD
🇧🇬Sofia, Bulgaria
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
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Southeast Regional Res Group
🇺🇸Savannah, Georgia, United States
S. Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
ISA Clinical Research
🇺🇸Jamaica, New York, United States
MultiCare Health Center of Washington
🇺🇸Tacoma, Washington, United States
Piedmont Research Partners LLC
🇺🇸Indian Land, South Carolina, United States
Instituto Ave Pulmo
🇦🇷Mar Del Plata, Argentina
Fifth MHAT - Sofia EAD
🇧🇬Sofia, Bulgaria
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Investigaciones en Patologias Respiratorias
🇦🇷San Miguel de Tucuman, Argentina
Instituto Del Buen Aire
🇦🇷Santa Fe, Argentina
National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
🇧🇬Sofia, Bulgaria
Concordia Hospital,Repiratory Research
🇨🇦Winnipeg, Manitoba, Canada
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
🇧🇬Stara Zagora, Bulgaria
Matrai Állami Gyógyintézet ; Bronchológia
🇭🇺Mátraháza, Hungary
Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
🇭🇺Balassagyarmat, Hungary
CRU Hungary Kft
🇭🇺Miskolc, Hungary
Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés
🇭🇺Komárom, Hungary
Mohacsi Korhaz
🇭🇺Mohacs, Hungary
Markusovszky Egyetemi Oktatokorhaz; Tudogondozo
🇭🇺Szombathely, Hungary
Farmakontroll Bt.
🇭🇺Százhalombatta, Hungary
Oaxaca Site Management Organization
🇲🇽Oaxaca, Mexico
Poradnia Pulmonologiczna dla Doroslych
🇵🇱Lódz, Poland
Mazowieckie Centrum Badan Klinicznych S.C.
🇵🇱Grodzisk Mazowiecki, Poland
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
🇷🇺Novosibirsk, Russian Federation
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
🇵🇱Ruda Śląska, Poland
Central Clinical Hospital #1 of RZhD JCS
🇷🇺Moscow, Russian Federation
State Novosibirsk Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
LLC Medical Center "Alliance-Biomedical - Russian Group"
🇷🇺Saint Petersburg, Russian Federation
LLC Reafan
🇷🇺Novosibirsk, Russian Federation
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
🇷🇺St Petersburg, Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov
🇷🇺St. Petersburg, Russian Federation
Siberian State Medical University
🇷🇺Tomsk, Russian Federation
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada