A Phase 3 study to evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with asthma that is not controlled.

• Register: EUCTR
• Last refreshed on: 30 October 2017
• Main ID: EUCTR2013-005614-35-PL
• Date of registration: 22/07/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A Phase 3 study to evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with asthma that is not controlled.
• Scientific title: 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 - STRATOS1
• Date of first enrolment: 10/09/2014
• Target sample size: 1140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005614-35
• Study type: Interventional clinical trial of medicinal product
• Study design: 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: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, Brazil, Bulgaria, Colombia, Germany, Hungary, Korea, Republic of, Peru, Poland, Slovakia, Spain, United States, Vietnam

Contacts

• Name: Eva Augurell
• Affiliation: AstraZeneca AB

• Name: Eva Augurell
• Affiliation: AstraZeneca AB

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age 12 -75
2. Documented physician-diagnosed asthma.
3. Documented treatment with ICS at a total daily dose corresponding to =500µg fluticasone propionate dry powder formulation equivalents) and a LABA
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
1. 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

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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
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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 0 to Week 52

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 long-acting ß2-agonist

Primary end point(s): Annual asthma exacerbation rate

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 tralokinumab

Secondary Outcome(s)

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 Dimension 5 Level Daily Living Questionnaire
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, electrocardiogram, laboratory values and vital signs

Timepoint(s) of evaluation of this end point: Week 0 to Week 52

- endpoints 1-9

Week 0 to Week 72

- endpoints 10-11

Secondary ID(s)

D2210C00007

NCT02161757

2013-005614-35-DE

Source(s) of Monetary Support

AstraZeneca AB