Download PDF

Clinical Trial Results:
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)

Summary
EudraCT number	2015-000857-19
Trial protocol	GB DK
Global end of trial date	21 Jun 2017

Results information
Results version number	v1(current)
This version publication date	23 May 2018
First version publication date	23 May 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

D2210C00014

ISRCTN number

US NCT number

NCT02449473

WHO universal trial number (UTN)

Sponsor organisation name

AstraZeneca

Sponsor organisation address

200 Orchard Ridge Drive, Gaithersburg, United States, MD 20878

Public contact

Global Clinical Lead, AstraZeneca, 1 3013980582, ClinicalTrialTransparency@astrazeneca.com

Scientific contact

Global Clinical Lead, AstraZeneca, 1 3013980582, ClinicalTrialTransparency@astrazeneca.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

21 Jun 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Jun 2017

Global end of trial reached?

Yes

Global end of trial date

21 Jun 2017

Was the trial ended prematurely?

Main objective of the trial

To evaluate the effect of tralokinumab on eosinophilic airway infiltration in adult patients with asthma inadequately controlled with inhaled corticosteroid (ICS).

Protection of trial subjects

This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics.

Background therapy

Patients were maintained on their currently prescribed ICS (≥250 micrograms fluticasone dry powder formulation equivalents total daily dose) + any additional maintenance asthma controller medication throughout the study.

Evidence for comparator

Actual start date of recruitment

29 Sep 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 45

Country: Number of subjects enrolled

Denmark: 23

Country: Number of subjects enrolled

Canada: 11

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

First patient enrolled: 29 Sep 2015; Last patient last visit: 21 Jun 2017. Study performed at 14 sites in 3 countries.

Screening details

224 patients signed informed consent, 172 entered screening/run-in period, 79 patients were randomised to receive investigational product (IP) and all those randomised received treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

Neither the patient nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation and monitoring of the patients will be aware of the study treatment received. Since tralokinumab and placebo are visually distinct, IP will be handled by an unblinded IP manager at the site and will be administered by an unblinded investigational site study team member who will not be involved in the management of study patients.

Are arms mutually exclusive

Yes

Tralo 300 mg Q2W

Arm description

Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 12-week treatment period (up to 6 doses).

Arm type

Experimental

Investigational medicinal product name

Tralokinumab

Investigational medicinal product code

CAT-354

Other name

Tralo

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

150 milligrams/millilitre (mg/mL) solution for injection in an accessorised pre-filled syringe, 1.0 mL fill volume. Each patient received 2 subcutaneous injections of 150 mg tralokinumab at each dosing interval to receive a total dose of 300 mg.

Placebo

Arm description

Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo solution for injection in an accessorised pre-filled syringe, 1.0 mL fill volume. Each patient received 2 subcutaneous injections of placebo at each dosing interval.

Number of subjects in period 1	Tralo 300 mg Q2W	Placebo
Started	39	40
Completed	39	40

Baseline characteristics

Top of page

Reporting group title

Tralo 300 mg Q2W

Reporting group description

Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 12-week treatment period (up to 6 doses).

Reporting group title

Placebo

Reporting group description

Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).

Reporting group values	Tralo 300 mg Q2W	Placebo	Total
Number of subjects	39	40	79
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	34	32	66
From 65-84 years	5	8	13
85 years and over	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	47.1 ± 14.2	50.1 ± 14.2	-
Sex: Female, Male
Units: Subjects
Female	23	20	43
Male	16	20	36
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	3	0	3
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	1	3
White	34	39	73
More than one race	0	0	0
Unknown or Not Reported	0	0	0

End points

Top of page

Reporting group title

Tralo 300 mg Q2W

Reporting group description

Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 12-week treatment period (up to 6 doses).

Reporting group title

Placebo

Reporting group description

Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).

Primary: Change from baseline to Week 12, expressed as a ratio, in number of airway submucosal eosinophils

Top of page

End point title

Change from baseline to Week 12, expressed as a ratio, in number of airway submucosal eosinophils

End point description

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 (back-transformed to be original scale), with standard deviation (SD) values presented on the log scale. Results are presented for the FAS comprising all randomised patients who received any IP.

End point type

Primary

End point timeframe

Baseline (Week 0) and Week 12

End point values	Tralo 300 mg Q2W	Placebo
Number of subjects analysed	35	39
Units: Ratio
geometric mean (standard deviation)	1.29 ± 2.06	1.07 ± 1.87

Change from baseline; airway submucosal eosinophil

Statistical analysis description

Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.

Comparison groups

Tralo 300 mg Q2W v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.3862

Method

ANCOVA

Parameter type

Least square (LS) geometric mean ratio

Point estimate

1.43

Confidence interval

level

95%

sides

2-sided

lower limit

0.63

upper limit

3.27

Notes
[1] - The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of blood eosinophils

Top of page

End point title

Change from baseline to Week 12, expressed as a ratio, in number of blood eosinophils

End point description

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 (back-transformed to be original scale), with SD values presented on the log scale. Results are presented for the FAS comprising all randomised patients who received any IP.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Week 12

End point values	Tralo 300 mg Q2W	Placebo
Number of subjects analysed	33	37
Units: Ratio
geometric mean (standard deviation)	1.10 ± 0.38	0.91 ± 0.46

Change from baseline; blood eosinophils

Statistical analysis description

Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.

Comparison groups

Tralo 300 mg Q2W v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.0546

Method

Repeated measures analysis

Parameter type

LS geometric mean ratio

Point estimate

1.21

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

1.48

Notes
[2] - The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of differential sputum eosinophils

Top of page

End point title

Change from baseline to Week 12, expressed as a ratio, in number of differential sputum eosinophils

End point description

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 (back-transformed to be original scale), with SD values presented on the log scale. Results are presented for the FAS comprising all randomised patients who received any IP.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Week 12

End point values	Tralo 300 mg Q2W	Placebo
Number of subjects analysed	16	17
Units: Ratio
geometric mean (standard deviation)	0.20 ± 3.16	0.47 ± 3.63

Change from baseline; induced sputum eosinophils

Statistical analysis description

Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.

Comparison groups

Tralo 300 mg Q2W v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 0.6334

Method

Repeated measures analysis

Parameter type

LS geometric mean ratio

Point estimate

0.57

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

Notes
[3] - The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.

Secondary: Change from baseline to Week 12, expressed as a ratio, in blood free eosinophil cationic protein (ECP) concentrations

Top of page

End point title

Change from baseline to Week 12, expressed as a ratio, in blood free eosinophil cationic protein (ECP) concentrations

End point description

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 (back-transformed to be original scale), with SD values presented on the log scale. Results are presented for the FAS comprising all randomised patients who received any IP.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Week 12

End point values	Tralo 300 mg Q2W	Placebo
Number of subjects analysed	24	28
Units: Ratio
geometric mean (standard deviation)	1.07 ± 0.40	0.92 ± 0.47

Change from baseline; blood free ECP

Statistical analysis description

Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.

Comparison groups

Tralo 300 mg Q2W v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

P-value

= 0.3769

Method

Repeated measures analysis

Parameter type

LS geometric mean ratio

Point estimate

1.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.88

upper limit

1.4

Notes
[4] - The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.

Secondary: Change from baseline to Week 12, expressed as a ratio, in sputum free ECP concentrations

Top of page

End point title

Change from baseline to Week 12, expressed as a ratio, in sputum free ECP concentrations

End point description

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 (back-transformed to be original scale), with SD values presented on the log scale. Results are presented for the FAS comprising all randomised patients who received any IP.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Week 12

End point values	Tralo 300 mg Q2W	Placebo
Number of subjects analysed	16	17
Units: Ratio
geometric mean (standard deviation)	0.66 ± 1.21	1.83 ± 1.41

Change from baseline; sputum free ECP

Statistical analysis description

Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.

Comparison groups

Tralo 300 mg Q2W v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

= 0.1126

Method

Repeated measures analysis

Parameter type

LS geometric mean ratio

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

1.2

Notes
[5] - The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.

Adverse events

Top of page

Timeframe for reporting adverse events

12 weeks

Adverse event reporting additional description

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.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Tralo 300 mg Q2W

Reporting group description

Tralokinumab 300 mg administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).

Reporting group title

Placebo

Reporting group description

Placebo administered subcutaneously Q2W over a 12-week treatment period (up to 6 doses).

Serious adverse events	Tralo 300 mg Q2W	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 39 (0.00%)	1 / 40 (2.50%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 39 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Tralo 300 mg Q2W	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	30 / 39 (76.92%)	27 / 40 (67.50%)
Investigations
Weight increased
subjects affected / exposed	2 / 39 (5.13%)	1 / 40 (2.50%)
occurrences all number	2	1
Injury, poisoning and procedural complications
Procedural pain
subjects affected / exposed	0 / 39 (0.00%)	3 / 40 (7.50%)
occurrences all number	0	3
Nervous system disorders
Headache
subjects affected / exposed	2 / 39 (5.13%)	9 / 40 (22.50%)
occurrences all number	2	18
General disorders and administration site conditions
Injection site erythema
subjects affected / exposed	3 / 39 (7.69%)	0 / 40 (0.00%)
occurrences all number	3	0
Injection site pain
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	3	0
Injection site pruritus
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	3	0
Injection site swelling
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	3	0
Non-cardiac chest pain
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	2	0
Fatigue
subjects affected / exposed	1 / 39 (2.56%)	3 / 40 (7.50%)
occurrences all number	1	3
Gastrointestinal disorders
Vomiting
subjects affected / exposed	3 / 39 (7.69%)	2 / 40 (5.00%)
occurrences all number	3	3
Nausea
subjects affected / exposed	2 / 39 (5.13%)	1 / 40 (2.50%)
occurrences all number	2	2
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	6 / 39 (15.38%)	2 / 40 (5.00%)
occurrences all number	7	2
Cough
subjects affected / exposed	3 / 39 (7.69%)	2 / 40 (5.00%)
occurrences all number	4	3
Rhinorrhoea
subjects affected / exposed	3 / 39 (7.69%)	0 / 40 (0.00%)
occurrences all number	3	0
Dyspnoea
subjects affected / exposed	2 / 39 (5.13%)	1 / 40 (2.50%)
occurrences all number	2	1
Epistaxis
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	2	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	3	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	2	0
Infections and infestations
Viral upper respiratory tract infection
subjects affected / exposed	8 / 39 (20.51%)	17 / 40 (42.50%)
occurrences all number	10	20
Influenza
subjects affected / exposed	2 / 39 (5.13%)	0 / 40 (0.00%)
occurrences all number	2	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

26 Feb 2015

- Text was revised to state that all patients would be followed up for a period of 14 weeks and that women of child bearing potential only would have an on-site follow-up visit at Week 26 to ascertain their pregnancy status. This revision was implemented following a request by the Medicines and Healthcare products Regulatory Agency.

15 Jan 2016

- For completion of the eosinophil evaluation, secondary objectives were updated to include assessment of sputum eosinophil levels. Submucosal eosinophil staining was removed as an outcome variable since this was included in the primary outcome variable. - To clarify that functional respiratory imaging analysis was optional and may be performed later pending other results from the study as well as the outcome of the pivotal studies, exploratory objectives relating to airway volume and resistance for entire airway tree were updated. - Revisions were applied to other exploratory objectives for the following reasons: to build flexibility to perform additional exploratory analysis; to clarify that both pre-bronchodilator (BD); and post-BD spirometry could be included; to allow the acceptance of both ‘PC20’ (provocative concentration required to achieve a 20% reduction in forced expiratory volume in 1 second [FEV1]) and ‘PD20’ (provocative dose required to achieve a 20% reduction in FEV1) in the airway hyper-responsiveness exploratory objective outcome variable; to make the RNA exploratory objective more specific; to remove sputum eosinophils from the exploratory variables since this was included as a secondary outcome measure; to provide flexibility for spirometry assessments; to clarify that whole body plethysmography was to be performed post-BD. - Discontinuation criteria were revised to allow subjects with an asthma-related event requiring non-invasive ventilation to continue with IP.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The results for differential sputum eosinophils and sputum free ECP levels should be viewed cautiously due to the small sample size and wide variability in results for sputum analyses.

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from baseline to Week 12, expressed as a ratio, in number of airway submucosal eosinophils

Primary: Change from baseline to Week 12, expressed as a ratio, in number of airway submucosal eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of blood eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of blood eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of differential sputum eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of differential sputum eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in blood free eosinophil cationic protein (ECP) concentrations

Secondary: Change from baseline to Week 12, expressed as a ratio, in blood free eosinophil cationic protein (ECP) concentrations

Secondary: Change from baseline to Week 12, expressed as a ratio, in sputum free ECP concentrations

Secondary: Change from baseline to Week 12, expressed as a ratio, in sputum free ECP concentrations

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from baseline to Week 12, expressed as a ratio, in number of airway submucosal eosinophils

Primary: Change from baseline to Week 12, expressed as a ratio, in number of airway submucosal eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of blood eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of blood eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of differential sputum eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in number of differential sputum eosinophils

Secondary: Change from baseline to Week 12, expressed as a ratio, in blood free eosinophil cationic protein (ECP) concentrations

Secondary: Change from baseline to Week 12, expressed as a ratio, in blood free eosinophil cationic protein (ECP) concentrations

Secondary: Change from baseline to Week 12, expressed as a ratio, in sputum free ECP concentrations

Secondary: Change from baseline to Week 12, expressed as a ratio, in sputum free ECP concentrations

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS)