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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546700
• Other study ID #: WB29804
• Secondary ID: 2015-001122-42
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2015
• Last updated: September 5, 2017
• Start date: September 30, 2015
• Est. completion date: November 25, 2016

Study information

• Verified date: September 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: November 25, 2016
• Est. primary completion date: November 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Argentina	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 Tucuman
Argentina	Instituto Del Buen Aire	Santa Fe
Bulgaria	Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology	Ruse
Bulgaria	Fifth MHAT - Sofia EAD	Sofia
Bulgaria	MHC - Sofia, EOOD	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
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Inspiration Research Limited	Toronto	Ontario
Canada	Concordia Hospital,Repiratory Research	Winnipeg	Manitoba
Denmark	Hvidovre Hospital, Lungemedicinsk Afdeling	Hvidovre
Denmark	Lungemedicinsk afd. L, Bispebjerg Hospital	København NV
Denmark	Odense Universitetshospital, Lungemedicinsk Forskningsenhed	Odense C
Hungary	Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )	Balassagyarmat
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Selye János Kórház és Rendelointézet; Allergológiai Szakrendelés	Komárom
Hungary	Matrai Állami Gyógyintézet ; Bronchológia	Mátraháza
Hungary	CRU Hungary Kft	Miskolc
Hungary	Mohacsi Korhaz	Mohacs
Hungary	Farmakontroll Bt.	Százhalombatta
Hungary	Markusovszky Egyetemi Oktatokorhaz; Tudogondozo	Szombathely
Mexico	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	Mexico
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Centro Integral Médico SJR SC	Querétaro
Poland	Mazowieckie Centrum Badan Klinicznych S.C.	Grodzisk Mazowiecki
Poland	Poradnia Pulmonologiczna dla Doroslych	Lódz
Poland	MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spólka Jawna	Lublin
Poland	Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala	Ruda Slaska
Poland	NZOZ Lekarze Specjalisci	Wroclaw
Russian Federation	Central Clinical Hospital #1 of RZhD JCS	Moscow
Russian Federation	FSI Scientific Research Inst	Moscow
Russian Federation	LLC Reafan	Novosibirsk
Russian Federation	Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2	Novosibirsk
Russian Federation	State Novosibirsk Regional Clinical Hospital	Novosibirsk
Russian Federation	LLC Medical Center "Alliance-Biomedical - Russian Group"	Saint Petersburg
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
United States	Comprehensive Clinical Research Inc.	Berlin	New Jersey
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Western Washington Medical Group	Everett	Washington
United States	Gastonia Pharmaceutical Research	Gastonia	North Carolina
United States	Baylor College of Medicine; Ben Taub Hospital- Guntupalli	Houston	Texas
United States	Centex Studies	Houston	Texas
United States	Piedmont Research Partners LLC	Indian Land	South Carolina
United States	ISA Clinical Research	Jamaica	New York
United States	Centex Studies	Lake Charles	Louisiana
United States	Clinical Research Inst. of Southern Oregon, Pc	Medford	Oregon
United States	Finlay Medical Research	Miami	Florida
United States	California Medical Research Associates, Inc.	Northridge	California
United States	Palmtree Clinical research Inc	Palm Springs	California
United States	Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC	Peoria	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	The Clinical Research Ctr	Saint Louis	Missouri
United States	Southeast Regional Res Group	Savannah	Georgia
United States	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	Premier Clinical Research	Spokane	Washington
United States	MultiCare Health Center of Washington	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Denmark,  Hungary,  Mexico,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12		Baseline, Week 12
Secondary	Rate of Moderate or Severe COPD Exacerbation		Baseline up to Week 24
Secondary	Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24		Baseline, Week 24
Secondary	Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24		Baseline, Week 24
Secondary	Time to First COPD Exacerbation		Baseline up to Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24		Baseline, Week 24
Secondary	Percentage of Participants with Adverse Events And Serious Adverse Events		Baseline up to Week 36
Secondary	Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab		Baseline up to Week 36
Secondary	Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin)		Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24
Secondary	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