A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
19 de maio de 2017 atualizado por: Hoffmann-La Roche
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
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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
230
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Queensland
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Brisbane, Queensland, Austrália, 4102
- Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
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Victoria
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Clayton, Victoria, Austrália, 3168
- Monash Medical Centre; Respiratory and Sleep Medicine
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Western Australia
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Nedlands, Western Australia, Austrália, 6009
- Institute for Respiratory Health Inc
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Bruxelles, Bélgica, 1070
- Clin Univ de Bxl Hôpital Erasme
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Genk, Bélgica, 3600
- Longartsenpraktijk
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Gent, Bélgica, 9000
- UZ Gent
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Ontario
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Toronto, Ontario, Canadá, M5T 3A9
- Inspiration Research Limited
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Hellerup, Dinamarca, 2900
- Gentofte Hospital, Klinik for Allergi
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Levice, Eslováquia, 934 01
- ZAPA JJ Sro
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Spisska Nova Ves, Eslováquia, 052 01
- Plucna ambulancia
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Golnik, Eslovênia, 4204
- University Clinic of Pulmonary and Allergic Diseases Golnik
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Barcelona, Espanha, 08036
- Hospital Clínic de Barcelona
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Barcelona, Espanha, 08025
- Hospital de la Santa Creu; i Sant Pau
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Salamanca, Espanha, 37007
- Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
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Valencia, Espanha, 46017
- Hospital Universitario Doctor Peset
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La Coruña
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Santiago de Compostela, La Coruña, Espanha, 15706
- Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
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California
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Bakersfield, California, Estados Unidos, 93301
- Kern Allergy Med Clinic, Inc.
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Long Beach, California, Estados Unidos, 90808
- Allergy & Asthma Care Center of Southern California
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Florida
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Miami, Florida, Estados Unidos, 33135
- South Florida Research Center, Inc.
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Georgia
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Albany, Georgia, Estados Unidos, 31707
- Georgia Pollens
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Allergy & Immunology
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Texas
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Houston, Texas, Estados Unidos, 77008
- Pioneer Research Solutions
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McKinney, Texas, Estados Unidos, 75069
- Metroplex Pulmonology & Sleep Center
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Pulmonary Consultants PLLC
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Grenoble Cedex 9, França, 38043
- CHU de Grenoble - Hôpital André Michallon
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Le Kremlin Bicetre, França, 94275
- CH de Bicetre; Pneumologie
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Lyon, França, 69004
- Hôpital de La Croix Rousse
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Montpellier, França, 34295
- Hôpital Arnaud de Villeneuve
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Nantes, França, 44093
- CHU Nantes - Hôpital Laennec; Service de Pneumologie
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Nice Cedex 1, França, 06001
- CHU de Nice
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Paris, França, 75877
- Hopital Bichat Claude Bernard ; Service de Pneumologie
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Pessac, França, 33604
- CHU de Haut Leveque
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Strabourg, França, 67091
- Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
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Amsterdam, Holanda, 1105 AZ
- Academisch Medisch Centrum; Afdeling Longziekten, F5-258
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Hoofddorp, Holanda, 2134 TM
- Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
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Nieuwegein, Holanda, 3435 CM
- Antonius Ziekenhuis; Dept of Lung Diseases
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Guadalajara, México, 44100
- Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
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Guadalajara, México, 44130
- Centro Investigacion Medico Biologica y Terapia Avanzada
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Querétaro, México, 76800
- Centro Integral Médico SJR SC
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Auckland, Nova Zelândia, 1051
- NZ Respiratory & Sleep Institute
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Dunedin, Nova Zelândia
- Dunedin Hospital
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Tauranga, Nova Zelândia, 3143
- Clinical Trials Unit, Bay of Plenty District Health Board
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Wellington, Nova Zelândia
- Medical Research Inst. of New Zealand; Respiratory
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Krakow, Polônia, 31-624
- Malopolskie Centrum Alergologii
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Krakow, Polônia, 31-024
- Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
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Lodz, Polônia, 90-153
- SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
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Ostrow Wielkopolski, Polônia, 63-400
- Specjalistyczna Poradnia Pulmonologiczna
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Ruda Śląska, Polônia, 41-707
- Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
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Warszawa, Polônia, 02-507
- Klinika Chorób Wewnetrznych i Alergologii MSW
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Wrocław, Polônia, 50-220
- EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
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Caguas, Porto Rico, 00725
- San Juan Bautista School of Medicine-Clinical Research Unit
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Cidra, Porto Rico, 00739
- Advanced Medical Concepts, PSC
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Belfast, Reino Unido, BT9 7AB
- Belfast City Hospital; Respiratory Department
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Birmingham, Reino Unido, B9 5SS
- Heartlands Hospital; Respiratory Department
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Glasgow, Reino Unido, G51 4TF
- Royal Hospital for Children
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Glasgow, Reino Unido, G12 0YN
- Gartnavel General Hospital; Respiratory Department
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Glasgow, Reino Unido, G31 2ER
- New Lister Buliding, Level 1; Clinical Research Facility
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Hampshire, Reino Unido, SO16 6YD
- Southampton General Hospital; Respiratory Department
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Leicester, Reino Unido, LE1 5WW
- Leicester Royal Infirmary NHS Trust
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Leicester, Reino Unido, LE3 9QP
- Glenfield Hospital; Respiratory -Allergy Unit
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London, Reino Unido, SW3 6NP
- Royal Brompton Hospital; Respiratory Department
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London, Reino Unido, EC1A 7BE
- St Bartholomew's Hospital (Barts); Respiratory Department
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Manchester, Reino Unido, M23 9LT
- Wythenshawe Hospital; North West Lung Research Centre
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Freeman Hospital; Respiratory Department
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Plymouth, Reino Unido, PL6 8DH
- Derriford Hospital; The Lind Research Department
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Sheffield, Reino Unido, S10 2JF
- Sheffield Clinical Research Facility; National Institute for Health Research
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Brno, Tcheca, 618 00
- Hornmed
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Liberec 1, Tcheca, 460 63
- Nemocnice Liberec; KNL a.s. - TRN
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Nový Jičín, Tcheca, 741-01
- Nemocnice Nový Jičín
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Rokycany, Tcheca, 337 22
- Rokycanska nemocnice
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
12 anos a 75 anos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Outros nomes:
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Experimental: 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.
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Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Outros nomes:
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Comparador de Placebo: 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.
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Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Outros nomes:
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Relative Change From Baseline in Daily OCS Dose at Week 44
Prazo: Baseline, Week 44
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Baseline, Week 44
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Absolute Change From Baseline in Daily OCS Dose at Week 44
Prazo: Baseline, Week 44
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Baseline, Week 44
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Relative Change From Week 12 in Average OCS Dose at Week 44
Prazo: Week 12, Week 44
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Week 12, Week 44
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Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
Prazo: Baseline, Week 44
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Baseline, Week 44
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Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Prazo: Week 44
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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.
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Week 44
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Percentage of Participants With Asthma Exacerbations
Prazo: Baseline up to Week 44
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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.
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Baseline up to Week 44
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Percentage of Participants With Adverse Events
Prazo: Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab
Prazo: 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)
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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)
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Minimum Observed Serum Lebrikizumab Concentration (Cmin)
Prazo: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
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Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de fevereiro de 2014
Conclusão Primária (Real)
20 de dezembro de 2016
Conclusão do estudo (Real)
20 de dezembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
12 de novembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de novembro de 2013
Primeira postagem (Estimativa)
19 de novembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WB28182
- 2012-000190-24 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .