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A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

19 maggio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

230

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre; Respiratory and Sleep Medicine
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Institute for Respiratory Health Inc
  • Belgio
      • Bruxelles, Belgio, 1070
        • Clin Univ de Bxl Hôpital Erasme
      • Genk, Belgio, 3600
        • Longartsenpraktijk
      • Gent, Belgio, 9000
        • UZ Gent
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Inspiration Research Limited
  • Cechia
      • Brno, Cechia, 618 00
        • Hornmed
      • Liberec 1, Cechia, 460 63
        • Nemocnice Liberec; KNL a.s. - TRN
      • Nový Jičín, Cechia, 741-01
        • Nemocnice Nový Jičín
      • Rokycany, Cechia, 337 22
        • Rokycanska nemocnice
  • Danimarca
      • Hellerup, Danimarca, 2900
        • Gentofte Hospital, Klinik for Allergi
  • Francia
      • Grenoble Cedex 9, Francia, 38043
        • CHU de Grenoble - Hôpital André Michallon
      • Le Kremlin Bicetre, Francia, 94275
        • CH de Bicetre; Pneumologie
      • Lyon, Francia, 69004
        • Hôpital de la Croix Rousse
      • Montpellier, Francia, 34295
        • Hopital Arnaud de Villeneuve
      • Nantes, Francia, 44093
        • CHU Nantes - Hôpital Laennec; Service de Pneumologie
      • Nice Cedex 1, Francia, 06001
        • CHU de Nice
      • Paris, Francia, 75877
        • Hopital Bichat Claude Bernard ; Service de Pneumologie
      • Pessac, Francia, 33604
        • CHU de Haut Leveque
      • Strabourg, Francia, 67091
        • Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
  • Messico
      • Guadalajara, Messico, 44100
        • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
      • Guadalajara, Messico, 44130
        • Centro Investigacion Medico Biologica y Terapia Avanzada
      • Querétaro, Messico, 76800
        • Centro Integral Médico SJR SC
  • Nuova Zelanda
      • Auckland, Nuova Zelanda, 1051
        • NZ Respiratory & Sleep Institute
      • Dunedin, Nuova Zelanda
        • Dunedin Hospital
      • Tauranga, Nuova Zelanda, 3143
        • Clinical Trials Unit, Bay of Plenty District Health Board
      • Wellington, Nuova Zelanda
        • Medical Research Inst. of New Zealand; Respiratory
  • Olanda
      • Amsterdam, Olanda, 1105 AZ
        • Academisch Medisch Centrum; Afdeling Longziekten, F5-258
      • Hoofddorp, Olanda, 2134 TM
        • Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
      • Nieuwegein, Olanda, 3435 CM
        • Antonius Ziekenhuis; Dept of Lung Diseases
  • Polonia
      • Krakow, Polonia, 31-624
        • Malopolskie Centrum Alergologii
      • Krakow, Polonia, 31-024
        • Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
      • Lodz, Polonia, 90-153
        • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
      • Ostrow Wielkopolski, Polonia, 63-400
        • Specjalistyczna Poradnia Pulmonologiczna
      • Ruda Śląska, Polonia, 41-707
        • Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
      • Warszawa, Polonia, 02-507
        • Klinika Chorób Wewnetrznych i Alergologii MSW
      • Wrocław, Polonia, 50-220
        • EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
  • Porto Rico
      • Caguas, Porto Rico, 00725
        • San Juan Bautista School of Medicine-Clinical Research Unit
      • Cidra, Porto Rico, 00739
        • Advanced Medical Concepts, PSC
  • Regno Unito
      • Belfast, Regno Unito, BT9 7AB
        • Belfast City Hospital; Respiratory Department
      • Birmingham, Regno Unito, B9 5SS
        • Heartlands Hospital; Respiratory Department
      • Glasgow, Regno Unito, G51 4TF
        • Royal Hospital For Children
      • Glasgow, Regno Unito, G12 0YN
        • Gartnavel General Hospital; Respiratory Department
      • Glasgow, Regno Unito, G31 2ER
        • New Lister Buliding, Level 1; Clinical Research Facility
      • Hampshire, Regno Unito, SO16 6YD
        • Southampton General Hospital; Respiratory Department
      • Leicester, Regno Unito, LE1 5WW
        • Leicester Royal Infirmary NHS Trust
      • Leicester, Regno Unito, LE3 9QP
        • Glenfield Hospital; Respiratory -Allergy Unit
      • London, Regno Unito, SW3 6NP
        • Royal Brompton Hospital; Respiratory Department
      • London, Regno Unito, EC1A 7BE
        • St Bartholomew's Hospital (Barts); Respiratory Department
      • Manchester, Regno Unito, M23 9LT
        • Wythenshawe Hospital; North West Lung Research Centre
      • Newcastle upon Tyne, Regno Unito, NE7 7DN
        • Freeman Hospital; Respiratory Department
      • Plymouth, Regno Unito, PL6 8DH
        • Derriford Hospital; The Lind Research Department
      • Sheffield, Regno Unito, S10 2JF
        • Sheffield Clinical Research Facility; National Institute for Health Research
  • Slovacchia
      • Levice, Slovacchia, 934 01
        • ZAPA JJ Sro
      • Spisska Nova Ves, Slovacchia, 052 01
        • Plucna ambulancia
  • Slovenia
      • Golnik, Slovenia, 4204
        • University Clinic of Pulmonary and Allergic Diseases Golnik
  • Spagna
      • Barcelona, Spagna, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spagna, 08025
        • Hospital de la Santa Creu; i Sant Pau
      • Salamanca, Spagna, 37007
        • Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
      • Valencia, Spagna, 46017
        • Hospital Universitario Doctor Peset
    • La Coruña
      • Santiago de Compostela, La Coruña, Spagna, 15706
        • Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
  • Stati Uniti
    • California
      • Bakersfield, California, Stati Uniti, 93301
        • Kern Allergy Med Clinic, Inc.
      • Long Beach, California, Stati Uniti, 90808
        • Allergy & Asthma Care Center of Southern California
    • Florida
      • Miami, Florida, Stati Uniti, 33135
        • South Florida Research Center, Inc.
    • Georgia
      • Albany, Georgia, Stati Uniti, 31707
        • Georgia Pollens
    • New York
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74136
        • Allergy & Immunology
    • Texas
      • Houston, Texas, Stati Uniti, 77008
        • Pioneer Research Solutions
      • McKinney, Texas, Stati Uniti, 75069
        • Metroplex Pulmonology & Sleep Center
    • Washington
      • Tacoma, Washington, Stati Uniti, 98405
        • Pulmonary Consultants PLLC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 75 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Altri nomi:
  • RO5490255
Sperimentale: 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.
Droga: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Altri nomi:
  • RO5490255
Comparatore 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.
Droga: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Altri nomi:
  • RO5490255
Droga: Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Relative Change From Baseline in Daily OCS Dose at Week 44
Lasso di tempo: Baseline, Week 44
Baseline, Week 44

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute Change From Baseline in Daily OCS Dose at Week 44
Lasso di tempo: Baseline, Week 44
Baseline, Week 44
Relative Change From Week 12 in Average OCS Dose at Week 44
Lasso di tempo: Week 12, Week 44
Week 12, Week 44
Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
Lasso di tempo: Baseline, Week 44
Baseline, Week 44
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Lasso di tempo: 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
Lasso di tempo: Baseline up to Week 44
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
Lasso di tempo: Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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
Lasso di tempo: 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)
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)
Lasso di tempo: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
Predose (0 hours) at Weeks 4, 12, 24, 36, and 44

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 febbraio 2014

Completamento primario (Effettivo)

20 dicembre 2016

Completamento dello studio (Effettivo)

20 dicembre 2016

Date di iscrizione allo studio

Primo inviato

12 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2013

Primo Inserito (Stima)

19 novembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • WB28182
  • 2012-000190-24 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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