A Phase IIa Study of KHK4563 (4563-003)
21. desember 2014 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
106
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Republikken
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Gwangju, Korea, Republikken
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Gyenggi-do, Korea, Republikken
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Seoul, Korea, Republikken
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Suwon-si, Korea, Republikken
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 2mg
sterile lyophilized formulation, 2mg
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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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Eksperimentell: 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.
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Eksperimentell: 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 komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først innsendt
7. august 2011
Først innsendt som oppfylte QC-kriteriene
8. august 2011
Først lagt ut (Anslag)
9. august 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4563-003
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