A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
Asthma
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1
- 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:
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- 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
Sites / Locations
- Kern Allergy Med Clinic, Inc.
- Allergy & Asthma Care Center of Southern California
- South Florida Research Center, Inc.
- Georgia Pollens
- Mount Sinai Medical Center
- Allergy & Immunology
- Pioneer Research Solutions
- Metroplex Pulmonology & Sleep Center
- Pulmonary Consultants PLLC
- Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
- Monash Medical Centre; Respiratory and Sleep Medicine
- Institute for Respiratory Health Inc
- Clin Univ de Bxl Hôpital Erasme
- Longartsenpraktijk
- UZ Gent
- Inspiration Research Limited
- Hornmed
- Nemocnice Liberec; KNL a.s. - TRN
- Nemocnice Nový Jičín
- Rokycanska nemocnice
- Gentofte Hospital, Klinik for Allergi
- CHU de Grenoble - Hôpital André Michallon
- CH de Bicetre; Pneumologie
- Hôpital de La Croix Rousse
- Hôpital Arnaud de Villeneuve
- CHU Nantes - Hôpital Laennec; Service de Pneumologie
- CHU de Nice
- Hopital Bichat Claude Bernard ; Service de Pneumologie
- CHU de Haut Leveque
- Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
- Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
- Centro Investigacion Medico Biologica y Terapia Avanzada
- Centro Integral Médico SJR SC
- Academisch Medisch Centrum; Afdeling Longziekten, F5-258
- Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
- Antonius Ziekenhuis; Dept of Lung Diseases
- NZ Respiratory & Sleep Institute
- Dunedin Hospital
- Clinical Trials Unit, Bay of Plenty District Health Board
- Medical Research Inst. of New Zealand; Respiratory
- Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
- Malopolskie Centrum Alergologii
- SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
- Specjalistyczna Poradnia Pulmonologiczna
- Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
- Klinika Chorób Wewnetrznych i Alergologii MSW
- EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
- San Juan Bautista School of Medicine-Clinical Research Unit
- Advanced Medical Concepts, PSC
- ZAPA JJ Sro
- Plucna ambulancia
- University Clinic of Pulmonary and Allergic Diseases Golnik
- Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
- Hospital de la Santa Creu; i Sant Pau
- Hospital Clinic de Barcelona
- Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
- Hospital Universitario Doctor Peset
- Belfast City Hospital; Respiratory Department
- Heartlands Hospital; Respiratory Department
- Gartnavel General Hospital; Respiratory Department
- New Lister Buliding, Level 1; Clinical Research Facility
- Royal Hospital For Children
- Southampton General Hospital; Respiratory Department
- Leicester Royal Infirmary NHS Trust
- Glenfield Hospital; Respiratory -Allergy Unit
- St Bartholomew's Hospital (Barts); Respiratory Department
- Royal Brompton Hospital; Respiratory Department
- Wythenshawe Hospital; North West Lung Research Centre
- Freeman Hospital; Respiratory Department
- Derriford Hospital; The Lind Research Department
- Sheffield Clinical Research Facility; National Institute for Health Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Lebrikizumab High Dose
Lebrikizumab Low Dose
Placebo
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.
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.
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.