Asthma Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma
Verified date | May 2017 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
Status | Completed |
Enrollment | 230 |
Est. completion date | December 20, 2016 |
Est. primary completion date | December 20, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | 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 |
Belgium | Clin Univ de Bxl Hôpital Erasme | Bruxelles | |
Belgium | Longartsenpraktijk | Genk | |
Belgium | UZ Gent | Gent | |
Canada | Inspiration Research Limited | Toronto | Ontario |
Czechia | Hornmed | Brno | |
Czechia | Nemocnice Liberec; KNL a.s. - TRN | Liberec 1 | |
Czechia | Nemocnice Nový Jicín | Nový Jicín | |
Czechia | Rokycanska nemocnice | Rokycany | |
Denmark | Gentofte Hospital, Klinik for Allergi | Hellerup | |
France | CHU de Grenoble - Hôpital André Michallon | Grenoble Cedex 9 | |
France | CH de Bicetre; Pneumologie | Le Kremlin Bicetre | |
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 Cedex 1 | |
France | Hopital Bichat Claude Bernard ; Service de Pneumologie | Paris | |
France | CHU de Haut Leveque | Pessac | |
France | Nouvel Hôpital Civil; Pôle de Pathologie Thoracique | Strabourg | |
Mexico | Centro Investigacion Medico Biologica y Terapia Avanzada | Guadalajara | |
Mexico | Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Guadalajara | |
Mexico | Centro Integral Médico SJR SC | Querétaro | |
Netherlands | Academisch Medisch Centrum; Afdeling Longziekten, F5-258 | Amsterdam | |
Netherlands | Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde | Hoofddorp | |
Netherlands | Antonius Ziekenhuis; Dept of Lung Diseases | Nieuwegein | |
New Zealand | 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 | |
Poland | Malopolskie Centrum Alergologii | Krakow | |
Poland | Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED | Krakow | |
Poland | SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | |
Poland | Specjalistyczna Poradnia Pulmonologiczna | Ostrow Wielkopolski | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala | Ruda Slaska | |
Poland | Klinika Chorób Wewnetrznych i Alergologii MSW | Warszawa | |
Poland | EMC Instytut Medyczny SA; Przychodnia przy ulicy Lowieckiej | Wroclaw | |
Puerto Rico | San Juan Bautista School of Medicine-Clinical Research Unit | Caguas | |
Puerto Rico | Advanced Medical Concepts, PSC | Cidra | |
Slovakia | ZAPA JJ Sro | Levice | |
Slovakia | Plucna ambulancia | Spisska Nova Ves | |
Slovenia | University Clinic of Pulmonary and Allergic Diseases Golnik | Golnik | |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu; i Sant Pau | Barcelona | |
Spain | Hospital Clinico Universitario de Salamanca; Servicio de Neumologia | Salamanca | |
Spain | Complejo Hospitalario Universitario de Santiago; Servicio de Neumología | Santiago de Compostela | La Coruña |
Spain | Hospital Universitario Doctor Peset | Valencia | |
United Kingdom | 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 | Glenfield Hospital; Respiratory -Allergy Unit | Leicester | |
United Kingdom | Leicester Royal Infirmary NHS Trust | Leicester | |
United Kingdom | Royal Brompton Hospital; Respiratory Department | London | |
United Kingdom | St Bartholomew's Hospital (Barts); 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 States | Georgia Pollens | Albany | Georgia |
United States | Kern Allergy Med Clinic, Inc. | Bakersfield | California |
United States | Pioneer Research Solutions | Houston | Texas |
United States | Allergy & Asthma Care Center of Southern California | Long Beach | California |
United States | Metroplex Pulmonology & Sleep Center | McKinney | Texas |
United States | South Florida Research Center, Inc. | Miami | Florida |
United States | Mount Sinai Medical Center | New York | New York |
United States | Pulmonary Consultants PLLC | Tacoma | Washington |
United States | Allergy & Immunology | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Australia, Belgium, Canada, Czechia, Denmark, France, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, Slovenia, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relative Change From Baseline in Daily OCS Dose at Week 44 | Baseline, Week 44 | ||
Secondary | Absolute Change From Baseline in Daily OCS Dose at Week 44 | Baseline, Week 44 | ||
Secondary | Relative Change From Week 12 in Average OCS Dose at Week 44 | Week 12, Week 44 | ||
Secondary | Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline | Baseline, Week 44 | ||
Secondary | Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44 | Percentage of participants discontinuing OCS therapy or having achieved adrenal maintenance dose (cortisol level less than or equal to 100 nanomoles per liter) will be reported. | Week 44 | |
Secondary | Percentage of Participants With Asthma Exacerbations | An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, or nocturnal awakenings due to these symptoms) that lead to treatment with systemic corticosteroids greater than or equal to (>/=) 30 milligrams (mg) or 0.5 mg per kilogram (kg) for >/=3 consecutive days or to hospitalization. | Baseline up to Week 44 | |
Secondary | Percentage of Participants With Adverse Events | Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years) | ||
Secondary | Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab | Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years) | ||
Secondary | Minimum Observed Serum Lebrikizumab Concentration (Cmin) | Predose (0 hours) at Weeks 4, 12, 24, 36, and 44 |
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