Clinical trial NCT02546700: A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 309
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Rate of Moderate or Severe COPD Exacerbation
timeFrame: Baseline up to Week 24
measure: Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24
timeFrame: Baseline, Week 24
measure: Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24
timeFrame: Baseline, Week 24
measure: Time to First COPD Exacerbation
timeFrame: Baseline up to Week 24
measure: 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
timeFrame: Baseline, Week 24
measure: Change From Baseline in COPD Symptoms as Measured by the Overall Score of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Cough and Sputum as Measured by the Cough and Sputum Domain Score of the EXACT at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants with Adverse Events And Serious Adverse Events
timeFrame: Baseline up to Week 36
measure: Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab
timeFrame: Baseline up to Week 36
measure: Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin)
timeFrame: Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 8, 12, 16, 20; at Weeks 24, 28, and 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC
state: Arizona
city: Northridge
country: United States
facility: California Medical Research Associates, Inc.
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical research Inc
state: California
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Res Group
state: Georgia
city: Lake Charles
country: United States
facility: Centex Studies
state: Louisiana
city: Saint Louis
country: United States
facility: The Clinical Research Ctr
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research Inc.
state: New Jersey
city: Jamaica
country: United States
facility: ISA Clinical Research
state: New York
city: Gastonia
country: United States
facility: Gastonia Pharmaceutical Research
state: North Carolina
city: Medford
country: United States
facility: Clinical Research Inst. of Southern Oregon, Pc
state: Oregon
city: Indian Land
country: United States
facility: Piedmont Research Partners LLC
state: South Carolina
city: Spartanburg
country: United States
facility: S. Carolina Pharmaceutical Research
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine; Ben Taub Hospital- Guntupalli
state: Texas
city: Houston
country: United States
facility: Centex Studies
state: Texas
city: Everett
country: United States
facility: Western Washington Medical Group
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health Center of Washington
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Médico Dra de Salvo
city: Mar Del Plata
country: Argentina
facility: Instituto Ave Pulmo
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: Santa Fe
country: Argentina
facility: Instituto Del Buen Aire
city: Ruse
country: Bulgaria
facility: Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology
city: Sofia
country: Bulgaria
facility: MHC - Sofia, EOOD
city: Sofia
country: Bulgaria
facility: Fifth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Tara OOD
city: Winnipeg
country: Canada
facility: Concordia Hospital,Repiratory Research
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Ontario
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Lungemedicinsk Afdeling
city: København NV
country: Denmark
facility: Lungemedicinsk afd. L, Bispebjerg Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Lungemedicinsk Forskningsenhed
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés
city: Miskolc
country: Hungary
facility: CRU Hungary Kft
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Mátraháza
country: Hungary
facility: Matrai Állami Gyógyintézet ; Bronchológia
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz; Tudogondozo
city: Százhalombatta
country: Hungary
facility: Farmakontroll Bt.
city: Durango
country: Mexico
facility: Centro de Investigacion y Atencion Integral Durango CIAID
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
city: Mexico
country: Mexico
facility: Centro Respiratorio de México
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Querétaro
country: Mexico
facility: Centro Integral Médico SJR SC
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badan Klinicznych S.C.
city: Lublin
country: Poland
facility: MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spółka Jawna
city: Lódz
country: Poland
facility: Poradnia Pulmonologiczna dla Doroslych
city: Ruda Śląska
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
city: Wroclaw
country: Poland
facility: NZOZ Lekarze Specjalisci
city: Moscow
country: Russian Federation
facility: FSI Scientific Research Inst
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital #1 of RZhD JCS
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: LLC Reafan
city: Saint Petersburg
country: Russian Federation
facility: LLC Medical Center "Alliance-Biomedical - Russian Group"
city: St Petersburg
country: Russian Federation
facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n.a. I.P. Pavlov
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: