A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Inadequately Controlled Asthma

Intervention / Treatment
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* Biological: Tralokinumab open-label


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label study to evaluate safety<br>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. | Biological: Tralokinumab open-label<br>* Subcutaneous injection; fixed dose; 300 mg<br>* Other names: Tralokinumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medium to high-dose of inhaled corticosteroid, long-acting β2-agonist, open-label study, tralokinumab, subcutaneous, inadequately controlled asthma, asthma