A Phase IIa Study of KHK4563 (4563-003)
21 december 2014 uppdaterad av: Kyowa Kirin Co., Ltd.
A Phase IIa , Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy and Safety of KHK4563 in Adults With Uncontrolled, Suspected Eosinophilic Asthma
This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
106
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Mizunami-shi, Japan
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Osakasayama-shi, Japan
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Oura-gun, Japan
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Seto-shi, Japan
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Aichi
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Nagoya-shi, Aichi, Japan
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Toyota-shi, Aichi, Japan
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Chiba
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Kamogawa-shi, Chiba, Japan
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan
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Gifu
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Ogaki-shi, Gifu, Japan
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan
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Hokkaido
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Sapporo-shi, Hokkaido, Japan
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Hyogo
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Himeji-shi, Hyogo, Japan
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Kobe-shi, Hyogo, Japan
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Kanagawa
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Sagamihara-shi, Kanagawa, Japan
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Yokohama-shi, Kanagawa, Japan
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan
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Kyoto
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Kyoto-shi, Kyoto, Japan
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Nagasaki
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Nagasaki-shi, Nagasaki, Japan
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Osaka
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Kishiwada-shi, Osaka, Japan
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Saitama
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Koshigaya-shi, Saitama, Japan
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Shizuoka
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Shizuoka-shi, Shizuoka, Japan
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Tokyo
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Itabashi-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Chungcheongbuk-do, Korea, Republiken av
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Gwangju, Korea, Republiken av
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Gyenggi-do, Korea, Republiken av
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Seoul, Korea, Republiken av
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Suwon-si, Korea, Republiken av
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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
20 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 20 through 75 years at the time of Week -3 visit.
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Physician prescribed daily use of medium-dose or high-dose ICS plus LABA or any combination of sequential dosing of either medium-dose or high-dose ICS/LABA for at least 12 months prior to Week -3 visit. Dose must be stable for at least 30 days prior to Week -3 visit.
- At least 2, but not more than 6, documented asthma exacerbations in the 12 months prior to Week -3 visit that required use of a systemic corticosteroid burst.
Exclusion Criteria
- Any condition (eg, any eosinophilic lower respiratory disease other than asthma, Churg-Strauss syndrome, hypereosinophilic syndrome, eosinophilic bronchitis, eosinophilic pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis or cystic fibrosis (CF)) that, in the opinion of the investigator or Medical Expert, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening period.
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: 2mg
sterile lyophilized formulation, 2mg
|
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
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Experimentell: 20mg
sterile lyophilized formulation, 20mg
|
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
|
|
Experimentell: 100mg
sterile lyophilized formulation, 100mg
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every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
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Placebo-jämförare: Placebo
two SC administration on day 1
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every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
Tidsram: Immediately following the first administration of study drug through Study Week 52.
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annual asthma exacerbation rate
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Immediately following the first administration of study drug through Study Week 52.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)
Tidsram: From first administration of study drug through Study Week 52.
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Pre-dose/pre-bronchodilator Forced Expiratory Volume in 1 Second ( FEV1 ) at the study centre, morning and evening peak expiratory flow (PEF)
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From first administration of study drug through Study Week 52.
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Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
Tidsram: From first administration of study drug through Study Week 52.
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ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
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From first administration of study drug through Study Week 52.
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Number of participants with Adverse Events as a Measure of Safety and Tolerability
Tidsram: From first administration of study drug through Study Week 68.
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Adverse Events/Serious Adverse Events (AE/SAE) - Laboratory variables - ECG (Electrocardiogram) - Physical Examination
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From first administration of study drug through Study Week 68.
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Time Profiles of Serum Concentration
Tidsram: From first administration of study drug through Study Week 68
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Serum benralizumab concentration
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From first administration of study drug through Study Week 68
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Immunogenicity by serum incidence rate of positive anti-drug antibody
Tidsram: From first administration of study drug through Study Week 68
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Anti-drug antibodies (ADA)
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From first administration of study drug through Study Week 68
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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
1 augusti 2011
Primärt slutförande (Faktisk)
1 juli 2013
Avslutad studie (Faktisk)
1 oktober 2013
Studieregistreringsdatum
Först inskickad
7 augusti 2011
Först inskickad som uppfyllde QC-kriterierna
8 augusti 2011
Första postat (Uppskatta)
9 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 december 2014
Senast verifierad
1 december 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4563-003
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 .