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

NCT02546700 | Completed Phase 2

• 2 other identifiers: WB298042015-001122-42
• Study Type: interventional
• Target: 309
• Locations: 9 countries
• Sites: 66

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12

  Baseline, Week 12

Secondary Outcomes (12)

• 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

• Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24

  Baseline, Week 24

• Time to First COPD Exacerbation

  Baseline up to 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

Study Arms (4)

Lebrikizumab: Biomarker-high

EXPERIMENTAL

Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.

Drug: Lebrikizumab

Lebrikizumab: Biomarker-low

EXPERIMENTAL

Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.

Drug: Lebrikizumab

Placebo: Biomarker-high

PLACEBO COMPARATOR

Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.

Drug: Placebo

Placebo: Biomarker-low

PLACEBO COMPARATOR

Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.

Drug: Placebo

Interventions

Lebrikizumab DRUG

Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.

Lebrikizumab: Biomarker-high; Lebrikizumab: Biomarker-low

Placebo DRUG

Matching placebo will be administered subcutaneously once in every 4 weeks.

Placebo: Biomarker-high; Placebo: Biomarker-low

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (66)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC

Peoria, Arizona, 85381, United States

Location

California Medical Research Associates, Inc.

Northridge, California, 91324, United States

Location

Palmtree Clinical research Inc

Palm Springs, California, 92262, United States

Location

Finlay Medical Research

Miami, Florida, 33126, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Southeast Regional Res Group

Savannah, Georgia, 31405, United States

Location

Centex Studies

Lake Charles, Louisiana, 70601, United States

Location

The Clinical Research Ctr

St Louis, Missouri, 63141, United States

Location

Comprehensive Clinical Research Inc.

Berlin, New Jersey, 08009, United States

Location

ISA Clinical Research

Jamaica, New York, 11435, United States

Location

Gastonia Pharmaceutical Research

Gastonia, North Carolina, 28054, United States

Location

Clinical Research Inst. of Southern Oregon, Pc

Medford, Oregon, 97504, United States

Location

Piedmont Research Partners LLC

Old Point Station, South Carolina, 29707, United States

Location

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

Baylor College of Medicine; Ben Taub Hospital- Guntupalli

Houston, Texas, 77030, United States

Location

Centex Studies

Houston, Texas, 77062, United States

Location

Western Washington Medical Group

Everett, Washington, 98208, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MultiCare Health Center of Washington

Tacoma, Washington, 98405, United States

Location

Centro Médico Dra de Salvo

Buenos Aires, C1426ABP, Argentina

Location

Instituto Ave Pulmo

Mar del Plata, CP 7600, Argentina

Location

Centro Respiratorio Quilmes

Quilmes, 1878, Argentina

Location

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, 4000, Argentina

Location

Instituto Del Buen Aire

Santa Fe, 3000, Argentina

Location

Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology

Rousse, 7002, Bulgaria

Location

MHC - Sofia, EOOD

Sofia, 1202, Bulgaria

Location

Fifth MHAT - Sofia EAD

Sofia, 1233, Bulgaria

Location

National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases

Sofia, 2233, Bulgaria

Location

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, 6000, Bulgaria

Location

Medical Center Tara OOD

Veliko Tarnovo, 5000, Bulgaria

Location

Concordia Hospital,Repiratory Research

Winnipeg, Manitoba, R2K 3S8, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Inspiration Research Limited

Toronto, Ontario, M5T 3A9, Canada

Location

Hvidovre Hospital, Lungemedicinsk Afdeling

Hvidovre, 2650, Denmark

Location

Lungemedicinsk afd. L, Bispebjerg Hospital

København NV, 2400, Denmark

Location

Odense Universitetshospital, Lungemedicinsk Forskningsenhed

Odense C, 5000, Denmark

Location

Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )

Balassagyarmat, 2660, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés

Komárom, 2900, Hungary

Location

Matrai Állami Gyógyintézet ; Bronchológia

Mátraháza, 3233, Hungary

Location

CRU Hungary Kft

Miskolc, 3529, Hungary

Location

Mohacsi Korhaz

Mohács, 7700, Hungary

Location

Farmakontroll Bt.

Százhalombatta, 2440, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz; Tudogondozo

Szombathely, 9700, Hungary

Location

Centro de Investigacion y Atencion Integral Durango CIAID

Durango, 34080, Mexico

Location

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

Guadalajara, 44100, Mexico

Location

Centro Respiratorio de México

México, 14050, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

Location

Centro Integral Médico SJR SC

Querétaro, 76800, Mexico

Location

Mazowieckie Centrum Badan Klinicznych S.C.

Grodzisk Mazowiecki, 05-825, Poland

Location

Poradnia Pulmonologiczna dla Doroslych

Lódz, 90-153, Poland

Location

MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spółka Jawna

Lublin, 02-090, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

Ruda Śląska, 41-707, Poland

Location

NZOZ Lekarze Specjalisci

Wroclaw, 54-239, Poland

Location

FSI Scientific Research Inst

Moscow, 105077, Russia

Location

Central Clinical Hospital #1 of RZhD JCS

Moscow, 125367, Russia

Location

Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

Novosibirsk, 630008, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

LLC Reafan

Novosibirsk, 630099, Russia

Location

LLC Medical Center "Alliance-Biomedical - Russian Group"

Saint Petersburg, 190068, Russia

Location

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

Saint Petersburg, 197089, Russia

Location

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

Saint Petersburg, 197089, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: September 30, 2015
• Primary Completion: November 25, 2016
• Study Completion: November 25, 2016
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

US (21); RU (9); AR (5); PL (5); HU (8); DK (3); ME (5); BU (6); CA (4)