A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
NCT ID: NCT01987492
Last Updated: 2017-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
230 participants
INTERVENTIONAL
2014-02-28
2016-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT01872689
A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis
NCT07201051
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
NCT05628740
Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
NCT05415137
Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis
NCT02024555
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lebrikizumab High Dose
Participants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Lebrikizumab Low Dose
Participants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Placebo
Participants will receive placebo matching to lebrikizumab SC injection every 4 weeks during the 44-week DBPC period. Participants will then be randomized to receive either high- or low-dose lebrikizumab every 4 weeks during the 32-week ATE period and will continue same treatment in the LTE period.
Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Baseline forced expiratory volume in 1 second (FEV1) \>/=40% of predicted prior to randomization
* Receiving high doses of inhaled glucocorticosteroids at a total daily dose of \>/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
* Chronic treatment with maintenance OCS for \>/=6 months prior to Visit 1
* Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
Exclusion Criteria
* Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
* For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
* For adolescents: History of active tuberculosis requiring treatment
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* Known current malignancy or current evaluation for a potential malignancy
* History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
* Infection requiring hospital admission or requiring treatment with 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 infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
* Current smoker or former smoker with a smoking history of more than 15 pack-years
* Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
* Use of a licensed or investigational monoclonal antibody other than anti-interleukin (IL)-13 or anti-IL-4/IL-13, including but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
* Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study
12 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, United States
South Florida Research Center, Inc.
Miami, Florida, United States
Georgia Pollens
Albany, Georgia, United States
Mount Sinai Medical Center
New York, New York, United States
Allergy & Immunology
Tulsa, Oklahoma, United States
Pioneer Research Solutions
Houston, Texas, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, United States
Pulmonary Consultants PLLC
Tacoma, Washington, United States
Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
Brisbane, Queensland, Australia
Monash Medical Centre; Respiratory and Sleep Medicine
Clayton, Victoria, Australia
Institute for Respiratory Health Inc
Nedlands, Western Australia, Australia
Clin Univ de Bxl Hôpital Erasme
Brussels, , Belgium
Longartsenpraktijk
Genk, , Belgium
UZ Gent
Ghent, , Belgium
Inspiration Research Limited
Toronto, Ontario, Canada
Hornmed
Brno, , Czechia
Nemocnice Liberec; KNL a.s. - TRN
Liberec, , Czechia
Nemocnice Nový Jičín
Nový Jičín, , Czechia
Rokycanska nemocnice
Rokycany, , Czechia
Gentofte Hospital, Klinik for Allergi
Hellerup, , Denmark
CHU de Grenoble - Hôpital André Michallon
Grenoble, , France
CH de Bicetre; Pneumologie
Le Kremlin-Bicêtre, , France
Hôpital de La Croix Rousse
Lyon, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU Nantes - Hôpital Laennec; Service de Pneumologie
Nantes, , France
CHU de Nice
Nice, , France
Hopital Bichat Claude Bernard ; Service de Pneumologie
Paris, , France
CHU de Haut Leveque
Pessac, , France
Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
Strabourg, , France
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, , Mexico
Centro Investigacion Medico Biologica y Terapia Avanzada
Guadalajara, , Mexico
Centro Integral Médico SJR SC
Querétaro, , Mexico
Academisch Medisch Centrum; Afdeling Longziekten, F5-258
Amsterdam, , Netherlands
Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
Hoofddorp, , Netherlands
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein, , Netherlands
NZ Respiratory & Sleep Institute
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Clinical Trials Unit, Bay of Plenty District Health Board
Tauranga, , New Zealand
Medical Research Inst. of New Zealand; Respiratory
Wellington, , New Zealand
Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
Krakow, , Poland
Malopolskie Centrum Alergologii
Krakow, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Specjalistyczna Poradnia Pulmonologiczna
Ostrów Wielkopolski, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
Ruda Śląska, , Poland
Klinika Chorób Wewnetrznych i Alergologii MSW
Warsaw, , Poland
EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
Wroclaw, , Poland
San Juan Bautista School of Medicine-Clinical Research Unit
Caguas, , Puerto Rico
Advanced Medical Concepts, PSC
Cidra, , Puerto Rico
ZAPA JJ Sro
Levice, , Slovakia
Plucna ambulancia
Spišská Nová Ves, , Slovakia
University Clinic of Pulmonary and Allergic Diseases Golnik
Golnik, , Slovenia
Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
Santiago de Compostela, La Coruña, Spain
Hospital de la Santa Creu; i Sant Pau
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
Salamanca, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Belfast City Hospital; Respiratory Department
Belfast, , United Kingdom
Heartlands Hospital; Respiratory Department
Birmingham, , United Kingdom
Gartnavel General Hospital; Respiratory Department
Glasgow, , United Kingdom
New Lister Buliding, Level 1; Clinical Research Facility
Glasgow, , United Kingdom
Royal Hospital For Children
Glasgow, , United Kingdom
Southampton General Hospital; Respiratory Department
Hampshire, , United Kingdom
Leicester Royal Infirmary NHS Trust
Leicester, , United Kingdom
Glenfield Hospital; Respiratory -Allergy Unit
Leicester, , United Kingdom
St Bartholomew's Hospital (Barts); Respiratory Department
London, , United Kingdom
Royal Brompton Hospital; Respiratory Department
London, , United Kingdom
Wythenshawe Hospital; North West Lung Research Centre
Manchester, , United Kingdom
Freeman Hospital; Respiratory Department
Newcastle upon Tyne, , United Kingdom
Derriford Hospital; The Lind Research Department
Plymouth, , United Kingdom
Sheffield Clinical Research Facility; National Institute for Health Research
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-000190-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WB28182
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.