Chronic Obstructive Pulmonary DiseasePhase 2NCT02546700
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Lebrikizumab in people with Chronic Obstructive Pulmonary Disease, run by Hoffmann-La Roche at 63 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 63 sitesin 9 countries
- Study dates
- 17 Sep 2015to 25 Nov 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
63 sites in 9 countries.
63 sites in 9 countries
United States19 sites
Comprehensive Clinical Research Inc.
Berlin, New Jersey, 08009
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Columbus Regional Research Institute
Columbus, Georgia, 31904
Western Washington Medical Group
Everett, Washington, 98208
Gastonia Pharmaceutical Research
Gastonia, North Carolina, 28054
Baylor College of Medicine; Ben Taub Hospital- Guntupalli
Houston, Texas, 77030
Centex Studies
Houston, Texas, 77058
ISA Clinical Research
Jamaica, New York, 11435
Centex Studies
Lake Charles, Louisiana, 70601
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, 97504
Finlay Medical Research
Miami, Florida, 33126
California Medical Research Associates, Inc.
Northridge, California, 91324
Palmtree Clinical research Inc
Palm Springs, California, 92262
Progressive Medical Research
Port Orange, Florida, 32127
Southeast Regional Res Group
Savannah, Georgia, 31405
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303
Premier Clinical Research
Spokane, Washington, 99202
The Clinical Research Ctr
St Louis, Missouri, 63141
MultiCare Health Center of Washington
Tacoma, Washington, 98405
Russia9 sites
FSI Scientific Research Inst
Moscow, 105077
Central Clinical Hospital #1 of RZhD JCS
Moscow, 125367
Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
Novosibirsk, 630008
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
LLC Reafan
Novosibirsk, 630099
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, Sankt-Peterburg, 197022
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, Sankt-Peterburg, 197089
LLC Medical Center "Alliance-Biomedical - Russian Group"
Saint Petersburg, 190068
Siberian State Medical University
Tomsk, 634050
Hungary8 sites
Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )
Balassagyarmat, 2660
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Selye János Kórház és Rendel?intézet; Allergológiai Szakrendelés
Komárom, 2900
Matrai Állami Gyógyintézet ; Bronchológia
Mátraháza, 3233
CRU Hungary Kft
Miskolc, 3529
Mohacsi Korhaz
Mohács, 7700
Farmakontroll Bt.
Százhalombatta, 2440
Markusovszky Egyetemi Oktatokorhaz; Tudogondozo
Szombathely, 9700
Bulgaria6 sites
Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology
Rousse, 7002
MHC - Sofia, EOOD
Sofia, 1202
Fifth MHAT - Sofia EAD
Sofia, 1233
National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
Sofia, 2233
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000
Medical Center Tara OOD
Veliko Tarnovo, 5000
Argentina5 sites
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP
Instituto Ave Pulmo
Mar del Plata, B7602DCK
Centro Respiratorio Quilmes
Quilmes, B1878FNR
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR
Instituto Del Buen Aire
Santa Fe, S3000ASF
Mexico5 sites
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, Durango, 34080
Centro Respiratorio de México
México, Mexico CITY (federal District), 14050
Oaxaca Site Management Organization
Oaxaca City, Oaxaca, 68000
Centro Integral Médico SJR SC
Querétaro, 76800
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Santa Cecilia, Jalisco, 44700
Poland5 sites
Mazowieckie Centrum Badan Klinicznych S.C.
Grodzisk Mazowiecki, 05-825
Poradnia Pulmonologiczna dla Doroslych
Lódz, 90-153
MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spó?ka Jawna
Lublin, 02-090
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
Ruda ?l?ska, 41-707
NZOZ Lekarze Specjalisci
Wroclaw, 54-239
Canada3 sites
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Inspiration Research
Toronto, Ontario, M5T 3A9
Denmark3 sites
Hvidovre Hospital, Lungemedicinsk Afdeling
Hvidovre, 2650
Lungemedicinsk afd. L, Bispebjerg Hospital
København NV, 2400
Odense Universitetshospital, Lungemedicinsk Forskningsenhed
Odense C, 5000
About this study
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
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
- Being tested
- Lebrikizumab, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
PlaceboDrug
Matching placebo will be administered subcutaneously once in every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 12
Adjusted mean change from baseline in pre-bronchodilator FEV1 (assessed using spirometry) at Week 12 was calculated.
Measured: Baseline, Week 12
Secondary outcomes (11)
Rate of Moderate or Severe COPD Exacerbation
A moderate COPD exacerbation was defined as new or increased COPD symptoms (for example, dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that lead to treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms (for example, dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that lead to hospitalization. Adjusted exacerbation rate per year was calculated.
Results are reported as a 'Number' representing the unadjusted annualized rate of COPD exacerbations per person-year. The total number of exacerbations observed during the period was defined as starting at the date of randomization and ending at most 172 days after randomization (including data collected during safety follow-up in the case of early drug discontinuation) regardless of adherence to study drug divided by the total patient-weeks at risk divided by 52 weeks per year.
Measured: Baseline up to Week 24
Change From Baseline in Post-bronchodilator FEV1 at Week 24
Adjusted mean change from baseline in post-bronchodilator FEV1 at Week 24 was calculated.
Measured: Baseline, Week 24
Change From Baseline in Pre-bronchodilator FEV1 at Week 24
Adjusted mean change from baseline in pre-bronchodilator FEV1 at Week 24 was calculated.
Measured: Baseline, Week 24
Time to First COPD Exacerbation
COPD exacerbation was defined as new or increased COPD symptoms (for example, dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days. Time to first COPD exacerbation was estimated using Kaplan-Meier analysis.
Measured: 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
SGRQ-C was assessed by asking participants to recall their COPD-related experiences and to respond to 40 questions included within three domains: symptoms (7 items), activity (13 items), and impacts (20 items). Overall SGRQ-C score ranged from 0 to 100, where lower score indicated better health-related quality of life. Change from baseline in overall SGRQ-C score at Week 24 was reported.
Measured: Baseline, 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
EXACT comprised of 14-item questionnaire containing four domains: breathlessness (5 items), cough and sputum (3 items), chest symptoms (3 items), and additional attributes (3 items). Overall EXACT score was the average of domain scores. It ranged from 0 to 100, where higher score indicated a more severe condition. Change from baseline in overall EXACT score at Week 24 was reported.
Measured: 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
EXACT comprised of 14-item questionnaire containing four domains: breathlessness (5 items), cough and sputum (3 items), chest symptoms (3 items), and additional attributes (3 items). Cough and Sputum domain score ranged from 0 to 100, where higher score indicated a more severe condition. Change from baseline in cough and sputum domain EXACT score at Week 24 was reported.
Measured: Baseline, Week 24
Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24
The BDI scores ranged from 0 (very severe impairment) to 4 (no impairment) for each of 3 domains (functional impairment, magnitude of task, and magnitude of effort) and were summed to determine the BDI total score (0 to 12). The TDI scores ranged from -3 (major deterioration) to +3 (major improvement) for each of the 3 domains (functional impairment, magnitude of task, and magnitude of effort). The sum of all domains yielded the TDI total score (-9 to +9). Change from baseline in BDI/TDI at Week 24 was reported.
Measured: Baseline, Week 24
Percentage of Participants With Anti-Therapeutic Antibody (ATA) to Lebrikizumab
This outcome measure was planned to be analyzed only in overall lebrikizumab arm.
Measured: Baseline up to Week 36
Minimum Observed Serum Trough Concentration (Cmin) of Lebrikizumab
This outcome measure was planned to be analyzed only in overall lebrikizumab arm.
Measured: Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24
Elimination Half-Life (t1/2) of Lebrikizumab
Elimination half-life was defined as the time measured for the serum concentration to decrease by one half. This outcome measure was planned to be analyzed only in overall lebrikizumab arm.
Measured: Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 12, 24, 28, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start17 Sep 2015
- Primary completion25 Nov 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546700
- Sponsor's protocol ID
- WB29804
- Other IDs
- 2015-001122-42, 2015
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2015
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov