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

19 maj 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

230

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Danmark
      • Hellerup, Danmark, 2900
        • Gentofte Hospital, Klinik for Allergi
  • Frankrike
      • Grenoble Cedex 9, Frankrike, 38043
        • CHU de Grenoble - Hôpital André Michallon
      • Le Kremlin Bicetre, Frankrike, 94275
        • CH de Bicetre; Pneumologie
      • Lyon, Frankrike, 69004
        • Hôpital de la Croix Rousse
      • Montpellier, Frankrike, 34295
        • Hopital Arnaud de Villeneuve
      • Nantes, Frankrike, 44093
        • CHU Nantes - Hôpital Laennec; Service de Pneumologie
      • Nice Cedex 1, Frankrike, 06001
        • CHU de Nice
      • Paris, Frankrike, 75877
        • Hopital Bichat Claude Bernard ; Service de Pneumologie
      • Pessac, Frankrike, 33604
        • CHU de Haut Leveque
      • Strabourg, Frankrike, 67091
        • Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
  • Förenta staterna
    • California
      • Bakersfield, California, Förenta staterna, 93301
        • Kern Allergy Med Clinic, Inc.
      • Long Beach, California, Förenta staterna, 90808
        • Allergy & Asthma Care Center of Southern California
    • Florida
      • Miami, Florida, Förenta staterna, 33135
        • South Florida Research Center, Inc.
    • Georgia
      • Albany, Georgia, Förenta staterna, 31707
        • Georgia Pollens
    • New York
      • New York, New York, Förenta staterna, 10029
        • Mount Sinai Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74136
        • Allergy & Immunology
    • Texas
      • Houston, Texas, Förenta staterna, 77008
        • Pioneer Research Solutions
      • McKinney, Texas, Förenta staterna, 75069
        • Metroplex Pulmonology & Sleep Center
    • Washington
      • Tacoma, Washington, Förenta staterna, 98405
        • Pulmonary Consultants PLLC
  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5T 3A9
        • Inspiration Research Limited
  • Mexiko
      • Guadalajara, Mexiko, 44100
        • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
      • Guadalajara, Mexiko, 44130
        • Centro Investigacion Medico Biologica y Terapia Avanzada
      • Querétaro, Mexiko, 76800
        • Centro Integral Médico SJR SC
  • Nederländerna
      • Amsterdam, Nederländerna, 1105 AZ
        • Academisch Medisch Centrum; Afdeling Longziekten, F5-258
      • Hoofddorp, Nederländerna, 2134 TM
        • Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
      • Nieuwegein, Nederländerna, 3435 CM
        • Antonius Ziekenhuis; Dept of Lung Diseases
  • Nya Zeeland
      • Auckland, Nya Zeeland, 1051
        • NZ Respiratory & Sleep Institute
      • Dunedin, Nya Zeeland
        • Dunedin Hospital
      • Tauranga, Nya Zeeland, 3143
        • Clinical Trials Unit, Bay of Plenty District Health Board
      • Wellington, Nya Zeeland
        • 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
  • Slovakien
      • Levice, Slovakien, 934 01
        • ZAPA JJ Sro
      • Spisska Nova Ves, Slovakien, 052 01
        • Plucna ambulancia
  • Slovenien
      • Golnik, Slovenien, 4204
        • University Clinic of Pulmonary and Allergic Diseases Golnik
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic 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
  • Storbritannien
      • Belfast, Storbritannien, BT9 7AB
        • Belfast City Hospital; Respiratory Department
      • Birmingham, Storbritannien, B9 5SS
        • Heartlands Hospital; Respiratory Department
      • Glasgow, Storbritannien, G51 4TF
        • Royal Hospital For Children
      • Glasgow, Storbritannien, G12 0YN
        • Gartnavel General Hospital; Respiratory Department
      • Glasgow, Storbritannien, G31 2ER
        • New Lister Buliding, Level 1; Clinical Research Facility
      • Hampshire, Storbritannien, SO16 6YD
        • Southampton General Hospital; Respiratory Department
      • Leicester, Storbritannien, LE1 5WW
        • Leicester Royal Infirmary NHS Trust
      • Leicester, Storbritannien, LE3 9QP
        • Glenfield Hospital; Respiratory -Allergy Unit
      • London, Storbritannien, SW3 6NP
        • Royal Brompton Hospital; Respiratory Department
      • London, Storbritannien, EC1A 7BE
        • St Bartholomew's Hospital (Barts); Respiratory Department
      • Manchester, Storbritannien, M23 9LT
        • Wythenshawe Hospital; North West Lung Research Centre
      • Newcastle upon Tyne, Storbritannien, NE7 7DN
        • Freeman Hospital; Respiratory Department
      • Plymouth, Storbritannien, PL6 8DH
        • Derriford Hospital; The Lind Research Department
      • Sheffield, Storbritannien, S10 2JF
        • Sheffield Clinical Research Facility; National Institute for Health Research
  • Tjeckien
      • Brno, Tjeckien, 618 00
        • Hornmed
      • Liberec 1, Tjeckien, 460 63
        • Nemocnice Liberec; KNL a.s. - TRN
      • Nový Jičín, Tjeckien, 741-01
        • Nemocnice Nový Jičín
      • Rokycany, Tjeckien, 337 22
        • Rokycanska nemocnice

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 75 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Andra namn:
  • RO5490255
Experimentell: 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.
Läkemedel: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Andra namn:
  • RO5490255
Placebo-jämförare: 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.
Läkemedel: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Andra namn:
  • RO5490255
Läkemedel: Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Relative Change From Baseline in Daily OCS Dose at Week 44
Tidsram: Baseline, Week 44
Baseline, Week 44

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 februari 2014

Primärt slutförande (Faktisk)

20 december 2016

Avslutad studie (Faktisk)

20 december 2016

Studieregistreringsdatum

Först inskickad

12 november 2013

Först inskickad som uppfyllde QC-kriterierna

12 november 2013

Första postat (Uppskatta)

19 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 maj 2017

Senast verifierad

1 maj 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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