A Phase 3 interventional study of Tralokinumab open-label in Inadequately Controlled Asthma, sponsored by AstraZeneca. Terminated at 3 sites in Japan. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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
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.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 28 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Subcutaneous injection; fixed dose; 300 mg
Also known as: Tralokinumab
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day -14 and Week 52.
Adult participants with asthma inadequately controlled on inhaled corticosteroid plus long-acting beta 2 agonist were recruited at 4 sites in Japan from 01 November 2016 until study termination on 24 January 2018. No adolescent participants were enrolled in the study.
| Milestone | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Started | 28 |
| Treatment received | 28 |
| Treatment completed | 2 |
| Completed | 0 |
| Not completed | 28 |
| Withdrew: Discontinuation of asthma program | 28 |
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.
| Participants | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Any AE | 21 |
| Any AE with outcome of death | 0 |
| Any SAE (including events with outcome of death) | 1 |
| Any AE leading to discontinuation of study drug | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over From Screening (Day -14) to study termination (Approximately 60 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tralokinumab 300 mg Every 2 Weeks (Q2W) | 0/28 (0%) | 1/28 (3.6%) | 21/28 (75%) |
| Event | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Chronic tonsillitisInfections and infestations | 1/28 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/28 |
| Event | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 10/28 |
| Injection site reactionGeneral disorders | 9/28 |
| InfluenzaInfections and infestations | 4/28 |
| HeadacheNervous system disorders | 3/28 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/28 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 3/28 |
| Oral herpesInfections and infestations | 2/28 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/28 |
| Abdominal pain upperGastrointestinal disorders | 2/28 |
| ContusionInjury, poisoning and procedural complications | 2/28 |
The safety analysis set included all participants enrolled and who received at least 1 dose of investigational product irrespective of their protocol adherence and continued participation in the study.
| Age, Categorical(Participants) | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 1 |
| Age, Continuous(Years) | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Mean | 47.7 ± 10.8 |
| Sex: Female, Male(Participants) | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Female | 15 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 28 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Tralokinumab 300 mg Every 2 Weeks (Q2W) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 28 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca