Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 April 2018 |
Main ID: |
EUCTR2013-005615-27-PL |
Date of registration:
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29/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 3 study to evaluate the Efficacy and Safety of Tralokinumab in Adults
and Adolescents with asthma that is not controlled.
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Scientific title:
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A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo
Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab
in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled
Corticosteroid Plus Long-Acting ß2-Agonist - STRATOS2 |
Date of first enrolment:
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24/12/2015 |
Target sample size:
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770 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005615-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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Chile
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Czech Republic
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Hong Kong
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Italy
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Japan
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Mexico
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Philippines
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Poland
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Russian Federation
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South Africa
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Eva Augurell
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Address:
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151 85
Sodertalje
Sweden |
Telephone:
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46317761315 |
Email:
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eva.augurell@astrazeneca.com |
Affiliation:
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AstraZeneca AB |
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Name:
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Eva Augurell
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Address:
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151 85
Sodertalje
Sweden |
Telephone:
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46317761315 |
Email:
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eva.augurell@astrazeneca.com |
Affiliation:
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AstraZeneca AB |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 12 -75 years
2. Documented physician-diagnosed asthma at least 12 months prior to enrollment.
3. Documented treatment with ICS at a total daily dose corresponding to =500µg fluticasone
propionate dry powder formulation equivalents and a LABA for at least 3 months.
4. Morning pre-BD FEV1 value of =40 and <80% value (<90% for patients 12 to 17 years of
age) of their PNV
5. Post-BD reversibility of =12% and =200 mL in FEV1
6. ACQ-6 score =1.5
7. At least 2 documented asthma exacerbations in the 12 months prior to the date of informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 77 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 653 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria: 1. Clinically important pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for = 10 pack-years
7. Previous receipt of tralokinumab
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma MedDRA version: 18.1
Level: PT
Classification code 10003553
Term: Asthma
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Name: Tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Tralokinumab CAS Number: 1044515-88-9 Current Sponsor code: CAT-354 Other descriptive name: CAT-354 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To assess the effect of tralokinumab with regards to lung function. To assess the effect of tralokinumab with regards to asthma symptoms. To assess the effect of tralokinumab with regards to asthma specific health-related quality of life. To assess the effect of tralokinumab with regards to ACQ-6 defined asthma control. To assess the effect of tralokinumab with regards to ER and urgent care visits and hospitalizations due to asthma. To assess the effect of tralokinumab with regards to health care resource utilization and productivity loss due to asthma. To assess the effect of tralokinumab with regards to health related quality of life. To assess the effect of tralokinumab with regards to asthma symptoms and asthma control. To evaluate the PK and immunogenicity of tralokinumab. To evaluate the safety and tolerability of tralokinumab.
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Main Objective: To evaluate the effect of tralokinumab compared with placebo on the annualised asthma exacerbation rate in adult and adolescent subjects with asthma that is inadequately controlled with inhaled corticosteroid plus longacting ß2-agonist.
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Timepoint(s) of evaluation of this end point: Week 0 to Week 52
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Primary end point(s): Annual asthma exacerbation rate
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Secondary Outcome(s)
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Secondary end point(s): 1. Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator forced expiratory volume in 1 second.
2. Change from baseline to Week 52 in daily asthma symptom score.
3. Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older total score.
4. Change from baseline to Week 52 in Asthma Control Questionnaire-6 defined asthma control.
5. Time to first asthma exacerbation and proportion of subjects with =1 asthma exacerbation.
6. Annualised asthma exacerbation rate that is associated with an ER or urgent care visit, or a hospitalization.
7. Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire and European Quality of Life -5 Dimensions - 5 Levels Daily Living Quesitonnaire.
8. Rescue medication use, Home peak expiratory flow (morning and evening).
9. Night-time awakening due to asthma.
10. Pharmacokinetic parameters and Anti-Drug Antibodies.
11. Safety and Tolerability of tralokinumab assessed by the reporting of adverse events/serious adverse events and assessments for physical examination, electocardiogram, laboratory values and vital signs.
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Timepoint(s) of evaluation of this end point: Week 0 to Week 52 (except PK and ADA, 0 to Week 72 weeks)
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Secondary ID(s)
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D2210C00008
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2013-005615-27-GB
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NCT02194699
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Source(s) of Monetary Support
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AstraZeneca AB
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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