- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02902809
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
26 juli 2019 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
28
Fas
- Fas 3
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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Chuo-ku, Japan, 103-0027
- Research Site
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Itabashi-ku, Japan, 173-8610
- Research Site
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Yokohama-shi, Japan, 236-0004
- Research Site
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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
12 år till 75 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
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Subcutaneous injection; fixed dose; 300 mg
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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.
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From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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Number of Participants With Clinical Laboratory Abnormalities
Tidsram: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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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.
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From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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Number of Participants With Abnormal Physical Examinations
Tidsram: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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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.
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From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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Number of Participants With Vital Signs Abnormalities
Tidsram: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.
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From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
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Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Tidsram: At Day -14 and Week 52.
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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.
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At Day -14 and Week 52.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Takeshi Kaneko, MD, PhD, Yokohama City University Graduate School of Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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)
11 november 2016
Primärt slutförande (Faktisk)
19 januari 2018
Avslutad studie (Faktisk)
19 januari 2018
Studieregistreringsdatum
Först inskickad
13 september 2016
Först inskickad som uppfyllde QC-kriterierna
13 september 2016
Första postat (Uppskatta)
16 september 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 september 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D2210C00029
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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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