Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000190-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab High Dose | Experimental | 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 Low Dose | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline in Daily OCS Dose at Week 44 | Baseline, Week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Daily OCS Dose at Week 44 | Baseline, Week 44 | |
| Relative Change From Week 12 in Average OCS Dose at Week 44 | Week 12, Week 44 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kern Allergy Med Clinic, Inc. | Bakersfield | California | 93301 | United States | ||
| Allergy & Asthma Care Center of Southern California |
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description. |
|
| Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline |
| Baseline, Week 44 |
| 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 |
| 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 |
| Percentage of Participants With Adverse Events | Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years) |
| 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) |
| Minimum Observed Serum Lebrikizumab Concentration (Cmin) | Predose (0 hours) at Weeks 4, 12, 24, 36, and 44 |
| Long Beach |
| California |
| 90808 |
| United States |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | United States |
| Georgia Pollens | Albany | Georgia | 31707 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Allergy & Immunology | Tulsa | Oklahoma | 74136 | United States |
| Pioneer Research Solutions | Houston | Texas | 77008 | United States |
| Metroplex Pulmonology & Sleep Center | McKinney | Texas | 75069 | United States |
| Pulmonary Consultants PLLC | Tacoma | Washington | 98405 | United States |
| Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine | Brisbane | Queensland | 4102 | Australia |
| Monash Medical Centre; Respiratory and Sleep Medicine | Clayton | Victoria | 3168 | Australia |
| Institute for Respiratory Health Inc | Nedlands | Western Australia | 6009 | Australia |
| Clin Univ de Bxl Hôpital Erasme | Brussels | 1070 | Belgium |
| Longartsenpraktijk | Genk | 3600 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Inspiration Research Limited | Toronto | Ontario | M5T 3A9 | Canada |
| Hornmed | Brno | 618 00 | Czechia |
| Nemocnice Liberec; KNL a.s. - TRN | Liberec | 460 63 | Czechia |
| Nemocnice Nový Jičín | Nový Jičín | 741-01 | Czechia |
| Rokycanska nemocnice | Rokycany | 337 22 | Czechia |
| Gentofte Hospital, Klinik for Allergi | Hellerup | 2900 | Denmark |
| CHU de Grenoble - Hôpital André Michallon | Grenoble | 38043 | France |
| CH de Bicetre; Pneumologie | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital de La Croix Rousse | Lyon | 69004 | France |
| Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU Nantes - Hôpital Laennec; Service de Pneumologie | Nantes | 44093 | France |
| CHU de Nice | Nice | 06001 | France |
| Hopital Bichat Claude Bernard ; Service de Pneumologie | Paris | 75877 | France |
| CHU de Haut Leveque | Pessac | 33604 | France |
| Nouvel Hôpital Civil; Pôle de Pathologie Thoracique | Strabourg | 67091 | France |
| Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Guadalajara | 44100 | Mexico |
| Centro Investigacion Medico Biologica y Terapia Avanzada | Guadalajara | 44130 | Mexico |
| Centro Integral Médico SJR SC | Querétaro | 76800 | Mexico |
| Academisch Medisch Centrum; Afdeling Longziekten, F5-258 | Amsterdam | 1105 AZ | Netherlands |
| Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde | Hoofddorp | 2134 TM | Netherlands |
| Antonius Ziekenhuis; Dept of Lung Diseases | Nieuwegein | 3435 CM | Netherlands |
| NZ Respiratory & Sleep Institute | Auckland | 1051 | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Clinical Trials Unit, Bay of Plenty District Health Board | Tauranga | 3143 | New Zealand |
| Medical Research Inst. of New Zealand; Respiratory | Wellington | New Zealand |
| Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED | Krakow | 31-024 | Poland |
| Malopolskie Centrum Alergologii | Krakow | 31-624 | Poland |
| SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | 90-153 | Poland |
| Specjalistyczna Poradnia Pulmonologiczna | Ostrów Wielkopolski | 63-400 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala | Ruda Śląska | 41-707 | Poland |
| Klinika Chorób Wewnetrznych i Alergologii MSW | Warsaw | 02-507 | Poland |
| EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej | Wroclaw | 50-220 | Poland |
| San Juan Bautista School of Medicine-Clinical Research Unit | Caguas | 00725 | Puerto Rico |
| Advanced Medical Concepts, PSC | Cidra | 00739 | Puerto Rico |
| ZAPA JJ Sro | Levice | 934 01 | Slovakia |
| Plucna ambulancia | Spišská Nová Ves | 052 01 | Slovakia |
| University Clinic of Pulmonary and Allergic Diseases Golnik | Golnik | 4204 | Slovenia |
| Complejo Hospitalario Universitario de Santiago; Servicio de Neumología | Santiago de Compostela | La Coruña | 15706 | Spain |
| Hospital de la Santa Creu; i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Clinico Universitario de Salamanca; Servicio de Neumologia | Salamanca | 37007 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| Belfast City Hospital; Respiratory Department | Belfast | BT9 7AB | United Kingdom |
| Heartlands Hospital; Respiratory Department | Birmingham | B9 5SS | United Kingdom |
| Gartnavel General Hospital; Respiratory Department | Glasgow | G12 0YN | United Kingdom |
| New Lister Buliding, Level 1; Clinical Research Facility | Glasgow | G31 2ER | United Kingdom |
| Royal Hospital For Children | Glasgow | G51 4TF | United Kingdom |
| Southampton General Hospital; Respiratory Department | Hampshire | SO16 6YD | United Kingdom |
| Leicester Royal Infirmary NHS Trust | Leicester | LE1 5WW | United Kingdom |
| Glenfield Hospital; Respiratory -Allergy Unit | Leicester | LE3 9QP | United Kingdom |
| St Bartholomew's Hospital (Barts); Respiratory Department | London | EC1A 7BE | United Kingdom |
| Royal Brompton Hospital; Respiratory Department | London | SW3 6NP | United Kingdom |
| Wythenshawe Hospital; North West Lung Research Centre | Manchester | M23 9LT | United Kingdom |
| Freeman Hospital; Respiratory Department | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Derriford Hospital; The Lind Research Department | Plymouth | PL6 8DH | United Kingdom |
| Sheffield Clinical Research Facility; National Institute for Health Research | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561806 | lebrikizumab |
Not provided
Not provided
Not provided