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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

NCT ID NCT02546700

NEW Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

309 people

The number who actually took part.

Started

Sep 2015

Finished

Nov 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pulmonary Disease, Chronic Obstructive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

Contacts and locations

Locations

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216, United States

  • Baylor College of Medicine; Ben Taub Hospital- Guntupalli

    Houston, Texas, 77030, United States

  • CRU Hungary Kft

    Miskolc, 3529, Hungary

  • California Medical Research Associates, Inc.

    Northridge, California, 91324, United States

  • Centex Studies

    Lake Charles, Louisiana, 70601, United States

  • Centex Studies

    Houston, Texas, 77058, United States

  • Central Clinical Hospital #1 of RZhD JCS

    Moscow, 125367, Russia

  • Centro Integral Médico SJR SC

    Querétaro, 76800, Mexico

  • Centro Médico Dra de Salvo

    Buenos Aires, C1426ABP, Argentina

  • Centro Respiratorio Quilmes

    Quilmes, B1878FNR, Argentina

  • Centro Respiratorio de México

    México, Mexico CITY (federal District), 14050, Mexico

  • Centro de Investigacion y Atencion Integral Durango CIAID

    Durango, Durango, 34080, Mexico

  • Clinical Research Inst. of Southern Oregon, Pc

    Medford, Oregon, 97504, United States

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904, United States

  • Comprehensive Clinical Research Inc.

    Berlin, New Jersey, 08009, United States

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

    Balassagyarmat, 2660, Hungary

  • FSI Scientific Research Inst

    Moscow, 105077, Russia

  • Farmakontroll Bt.

    Százhalombatta, 2440, Hungary

  • Fifth MHAT - Sofia EAD

    Sofia, 1233, Bulgaria

  • Finlay Medical Research

    Miami, Florida, 33126, United States

  • Gastonia Pharmaceutical Research

    Gastonia, North Carolina, 28054, United States

  • Hvidovre Hospital, Lungemedicinsk Afdeling

    Hvidovre, 2650, Denmark

  • ISA Clinical Research

    Jamaica, New York, 11435, United States

  • Inspiration Research

    Toronto, Ontario, M5T 3A9, Canada

  • Instituto Ave Pulmo

    Mar del Plata, B7602DCK, Argentina

  • Instituto Del Buen Aire

    Santa Fe, S3000ASF, Argentina

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

    Santa Cecilia, Jalisco, 44700, Mexico

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, T4000IAR, Argentina

  • LLC Medical Center "Alliance-Biomedical - Russian Group"

    Saint Petersburg, 190068, Russia

  • LLC Reafan

    Novosibirsk, 630099, Russia

  • Lungemedicinsk afd. L, Bispebjerg Hospital

    København NV, 2400, Denmark

  • MHC - Sofia, EOOD

    Sofia, 1202, Bulgaria

  • MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spó?ka Jawna

    Lublin, 02-090, Poland

  • Markusovszky Egyetemi Oktatokorhaz; Tudogondozo

    Szombathely, 9700, Hungary

  • Matrai Állami Gyógyintézet ; Bronchológia

    Mátraháza, 3233, Hungary

  • Mazowieckie Centrum Badan Klinicznych S.C.

    Grodzisk Mazowiecki, 05-825, Poland

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000, Bulgaria

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000, Bulgaria

  • Mohacsi Korhaz

    Mohács, 7700, Hungary

  • MultiCare Health Center of Washington

    Tacoma, Washington, 98405, United States

  • NZOZ Lekarze Specjalisci

    Wroclaw, 54-239, Poland

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

    Sofia, 2233, Bulgaria

  • Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

    Ruda ?l?ska, 41-707, Poland

  • Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

    Novosibirsk, 630008, Russia

  • Oaxaca Site Management Organization

    Oaxaca City, Oaxaca, 68000, Mexico

  • Odense Universitetshospital, Lungemedicinsk Forskningsenhed

    Odense C, 5000, Denmark

  • Palmtree Clinical research Inc

    Palm Springs, California, 92262, United States

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024, Hungary

  • Poradnia Pulmonologiczna dla Doroslych

    Lódz, 90-153, Poland

  • Premier Clinical Research

    Spokane, Washington, 99202, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303, United States

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

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • Selye János Kórház és Rendel?intézet; Allergológiai Szakrendelés

    Komárom, 2900, Hungary

  • Siberian State Medical University

    Tomsk, 634050, Russia

  • Southeast Regional Res Group

    Savannah, Georgia, 31405, United States

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

    Rousse, 7002, Bulgaria

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

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

    Saint Petersburg, Sankt-Peterburg, 197089, Russia

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087, Russia

  • The Clinical Research Ctr

    St Louis, Missouri, 63141, United States

  • Western Washington Medical Group

    Everett, Washington, 98208, United States

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