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

19. maj 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

230

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Andre navne:
  • RO5490255
Eksperimentel: 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.
Medicin: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Andre navne:
  • RO5490255
Placebo komparator: 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.
Medicin: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Andre navne:
  • RO5490255
Medicin: Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Relative Change From Baseline in Daily OCS Dose at Week 44
Tidsramme: Baseline, Week 44
Baseline, Week 44

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change From Baseline in Daily OCS Dose at Week 44
Tidsramme: Baseline, Week 44
Baseline, Week 44
Relative Change From Week 12 in Average OCS Dose at Week 44
Tidsramme: 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
Tidsramme: Baseline, Week 44
Baseline, Week 44
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
Predose (0 hours) at Weeks 4, 12, 24, 36, and 44

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. februar 2014

Primær færdiggørelse (Faktiske)

20. december 2016

Studieafslutning (Faktiske)

20. december 2016

Datoer for studieregistrering

Først indsendt

12. november 2013

Først indsendt, der opfyldte QC-kriterier

12. november 2013

Først opslået (Skøn)

19. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lebrikizumab

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