Trial Outcomes & Findings for Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids (NCT NCT02449473)
NCT ID: NCT02449473
Last Updated: 2019-01-08
Results Overview
The number of airway submucosal eosinophils per millimetre squared (mm\^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Baseline (Week 0) and Week 12
Results posted on
2019-01-08
Participant Flow
First patient enrolled: 29 Sep 2015; Last patient last visit: 21 Jun 2017. Study performed at 14 sites in 3 countries. Patients maintained on currently prescribed inhaled corticosteroid (≥250 micrograms fluticasone dry powder formulation equivalents total daily dose) + any additional maintenance asthma controller medication throughout the study.
79 patients were randomised to receive investigational product (IP) and all those randomised received treatment.
Participant milestones
| Measure |
Tralo 300 mg Q2W
Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 12-week treatment period (up to 6 doses).
|
Placebo
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
Baseline characteristics by cohort
| Measure |
Tralo 300 mg Q2W
n=39 Participants
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=40 Participants
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
50.1 Years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
48.6 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.
The number of airway submucosal eosinophils per millimetre squared (mm\^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.
Outcome measures
| Measure |
Tralo 300 mg Q2W
n=35 Participants
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=39 Participants
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils
|
1.29 Ratio
Standard Deviation 2.06
|
1.07 Ratio
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.
The blood eosinophil count was obtained from the total and differential white blood cell counts. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of blood eosinophils is presented as geometric mean ± SD of log values.
Outcome measures
| Measure |
Tralo 300 mg Q2W
n=33 Participants
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=37 Participants
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils
|
1.10 Ratio
Standard Deviation 0.38
|
0.91 Ratio
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.
Sputum induction was performed to obtain satisfactory samples of sputum originating from the airways. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of eosinophils in induced sputum is presented as geometric mean ± SD of log values.
Outcome measures
| Measure |
Tralo 300 mg Q2W
n=16 Participants
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=17 Participants
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils
|
0.20 Ratio
Standard Deviation 3.16
|
0.47 Ratio
Standard Deviation 3.63
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.
ECP concentrations were determined to assess evidence of activation of eosinophils in blood. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in blood free ECP concentrations is presented as geometric mean ± SD of log values.
Outcome measures
| Measure |
Tralo 300 mg Q2W
n=24 Participants
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=28 Participants
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations
|
1.07 Ratio
Standard Deviation 0.40
|
0.92 Ratio
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.
ECP concentrations were determined to assess evidence of activation of eosinophils in sputum. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in sputum free ECP concentrations is presented as geometric mean ± SD of log values.
Outcome measures
| Measure |
Tralo 300 mg Q2W
n=16 Participants
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=17 Participants
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations
|
0.66 Ratio
Standard Deviation 1.21
|
1.83 Ratio
Standard Deviation 1.41
|
Adverse Events
Tralo 300 mg Q2W
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tralo 300 mg Q2W
n=39 participants at risk
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=40 participants at risk
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
2.5%
1/40 • Number of events 1 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
Other adverse events
| Measure |
Tralo 300 mg Q2W
n=39 participants at risk
Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
Placebo
n=40 participants at risk
Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.5%
8/39 • Number of events 10 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
42.5%
17/40 • Number of events 20 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Infections and infestations
Influenza
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
22.5%
9/40 • Number of events 18 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
3/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
5.0%
2/40 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
2.5%
1/40 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
General disorders
Injection site erythema
|
7.7%
3/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
General disorders
Injection site pain
|
5.1%
2/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
General disorders
Injection site pruritus
|
5.1%
2/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
General disorders
Injection site swelling
|
5.1%
2/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
General disorders
Non-cardiac chest pain
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
General disorders
Fatigue
|
2.6%
1/39 • Number of events 1 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
7.5%
3/40 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Investigations
Weight increased
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
2.5%
1/40 • Number of events 1 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/39 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
7.5%
3/40 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.4%
6/39 • Number of events 7 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
5.0%
2/40 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 4 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
5.0%
2/40 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
3/39 • Number of events 3 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
2.5%
1/40 • Number of events 1 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
2/39 • Number of events 2 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
0.00%
0/40 • 12 weeks
Data is reported for adverse events during the treatment period (onset date ≥ the first day of IP and ≤ the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received any IP, classified according to the treatment they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60