- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02902809
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
26. juli 2019 opdateret af: AstraZeneca
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist.
Approximately 26 Japanese subjects will be recruited to receive 22 completed.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Chuo-ku, Japan, 103-0027
- Research Site
-
Itabashi-ku, Japan, 173-8610
- Research Site
-
Yokohama-shi, Japan, 236-0004
- Research Site
-
-
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:
- Age 12 - 75 yrs
- Documented physician-diagnosed asthma
- Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
- Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of their Predicted Normal Value (PNV)
- Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5
Exclusion Criteria:
- Pulmonary disease other than asthma
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant of breastfeeding
- History or cancer
- Current tobacco smoking or a history or tobacco smoking for ≥10 pack-years
- Previous receipt of tralokinumab
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Open-label study to evaluate safety
A fixed 300 mg dose every 2 weeks (Q2W) of tralokinumab administered subcutaneously in subjects with inadequately controlled asthma on medium to high-dose of inhaled corticosteroid plus long-acting β2-agonist.
|
Subcutaneous injection; fixed dose; 300 mg
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
An AE was development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to product.
An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation.
In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
A SAE was an AE occurred during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening, in-patient or prolongation of existing hospitalization; persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; congenital abnormality or birth defect; important medical event that may jeopardise participant or may require medical intervention to prevent one of the outcomes listed above.
|
From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Number of Participants With Clinical Laboratory Abnormalities
Tidsramme: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Blood and urine samples for determination of clinical chemistry, haematology and urinalysis parameters were taken at the times.
Changes in haematology and clinical chemistry variables between baseline and each subsequent scheduled assessment were evaluated.
Baseline is defined as the last available value measured prior to the first dose of study treatment.
The change from baseline is defined as the treatment period value minus the baseline period value.
Absolute values were compared to the relevant reference range and classified as low (below range), normal (within range or on limits) or high (above range).
The AstraZeneca extended reference ranges were used for laboratory variables (where they exist).
All values (absolute and change) falling outside the reference ranges were flagged.
Urinalysis data were categorised as negative (0), trace or positive (+) at each time point.
|
From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Number of Participants With Abnormal Physical Examinations
Tidsramme: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Physical examination included assessment of general appearance, skin, head and neck (including eyes, ears, nose, mouth and throat), lymph nodes, abdomen, musculoskeletal (including spine and extremities), cardiovascular, respiratory, and neurological systems.
Criteria for abnormal physical findings were based on investigator's discretion.
|
From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Number of Participants With Vital Signs Abnormalities
Tidsramme: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.
|
From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Tidsramme: At Day -14 and Week 52.
|
The ECG assessments were performed using an ECG device prior to blood drawing, spirometry, investigational product administration and bronchodilator administration.
ECG data and evaluation was planned to be performed by the site Investigator.
|
At Day -14 and Week 52.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Takeshi Kaneko, MD, PhD, Yokohama City University Graduate School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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)
11. november 2016
Primær færdiggørelse (Faktiske)
19. januar 2018
Studieafslutning (Faktiske)
19. januar 2018
Datoer for studieregistrering
Først indsendt
13. september 2016
Først indsendt, der opfyldte QC-kriterier
13. september 2016
Først opslået (Skøn)
16. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D2210C00029
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 Inadequately Controlled Asthma
-
First Hospital of China Medical UniversityAfsluttetGastrointestinal kirurgi | Thorax epidural anæstesi | Target Controlled Infusion (TCI) | Blok niveauKina
-
Universidad del DesarrolloAfsluttetGenerel anæstesi | Propofol farmakodynamik | Propofol Target Controlled Infusion | Bevidsthedstab og genopretning af bevidsthed | Propofol Plasma KoncentrationChile
Kliniske forsøg med Tralokinumab open-label
-
Scion NeuroStimTilmelding efter invitationParkinsons sygdom | Parkinsons sygdom og ParkinsonismeForenede Stater
-
OrphAI TherapeuticsAfsluttetAkut myeloid leukæmi | OnkologiForenede Stater
-
PfizerPfizerRekrutteringSeglcellesygdomForenede Stater, Nigeria
-
Universitätsklinikum Hamburg-EppendorfAfsluttet
-
University of California, San FranciscoRekruttering
-
University of Maryland, BaltimoreIkke rekrutterer endnuKronisk smerte | Hovedpine
-
ES Therapeutics Australia Pty LtdRekrutteringLægemiddelresistent epilepsiAustralien
-
Krystal Biotech, Inc.AfsluttetDystrofisk epidermolyse Bullosa | Recessiv dystrofisk epidermolysis Bullosa | Dominant dystrofisk epidermolysis Bullosa | DEB - Dystrophic Epidermolysis BullosaForenede Stater
-
Daewoong Pharmaceutical Co. LTD.AfsluttetModerat-alvorlige Glabellar-linjer