Trial Outcomes & Findings for A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (NCT NCT02902809)
NCT ID: NCT02902809
Last Updated: 2019-09-06
Results Overview
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.
TERMINATED
PHASE3
28 participants
From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
2019-09-06
Participant Flow
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.
Of all enrolled participants, 3 were considered screen failures and 28 participants were received study treatment. Following initial screening, there was a run-in period of up to 2 weeks to allow adequate time for eligibility criteria to be evaluated prior to entry to planned 52-week treatment period followed by a 14 week extended follow-up period.
Participant milestones
| Measure |
Tralokinumab 300 mg Every 2 Weeks (Q2W)
Participants were administered with tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
Treatment Received
|
28
|
|
Overall Study
Treatment Completed
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Tralokinumab 300 mg Every 2 Weeks (Q2W)
Participants were administered with tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks for 52 weeks.
|
|---|---|
|
Overall Study
Discontinuation of asthma program
|
28
|
Baseline Characteristics
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
Tralokinumab 300 mg Every 2 Weeks (Q2W)
n=28 Participants
Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).Population: 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.
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.
Outcome measures
| Measure |
Tralokinumab 300 mg Every 2 Weeks (Q2W)
n=28 Participants
Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE with outcome of death
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE (including events with outcome of death)
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE leading to discontinuation of study drug
|
1 Participants
|
PRIMARY outcome
Timeframe: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).Population: No participants were analysed as the study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings of clinical laboratory parameters were evaluated for safety signal.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).Population: The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. Any new finding(s) or aggravated existing finding(s), judged as clinically significant by the Investigator, were reported as an AE.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).Population: The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. No summary table was developed.
Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At Day -14 and Week 52.Population: The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. No summary table was developed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Tralokinumab 300 mg Every 2 Weeks (Q2W)
Serious adverse events
| Measure |
Tralokinumab 300 mg Every 2 Weeks (Q2W)
n=28 participants at risk
Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Chronic tonsillitis
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
Other adverse events
| Measure |
Tralokinumab 300 mg Every 2 Weeks (Q2W)
n=28 participants at risk
Participants were administered with tralokinumab 300 mg subcutaneous injection every 2 weeks for 52 weeks.
|
|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
35.7%
10/28 • Number of events 20 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Influenza
|
14.3%
4/28 • Number of events 4 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Oral herpes
|
7.1%
2/28 • Number of events 3 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Acute sinusitis
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Cystitis
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Oral candidiasis
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Otitis media acute
|
3.6%
1/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Pharyngitis
|
3.6%
1/28 • Number of events 4 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Tonsillitis
|
3.6%
1/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Number of events 4 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Nervous system disorders
Sciatica
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Eye disorders
Dry eye
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Vascular disorders
Hyperaemia
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
3/28 • Number of events 3 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.7%
3/28 • Number of events 4 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
2/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
2/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Gastrointestinal disorders
Cheilitis
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.6%
1/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
General disorders
Injection site reaction
|
32.1%
9/28 • Number of events 57 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
General disorders
Asthenia
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
General disorders
Injection site pain
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
General disorders
Injection site swelling
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Number of events 3 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
General disorders
Thirst
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
1/28 • Number of events 1 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
2/28 • Number of events 2 • From Screening (Day -14) to study termination (Approximately 60 weeks).
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60