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 June 2019
• Main ID: EUCTR2013-005615-27-GB
• Date of registration: 18/08/2014
• 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 - STRATOS2
• Date of first enrolment: 24/09/2014
• Target sample size: 770
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005615-27
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Chile, Czech Republic, Hong Kong, Italy, Japan, Mexico, Philippines, Poland, Russian Federation, South Africa, Ukraine, United Kingdom, United States

Contacts

• Name: Eva Augurell
• Affiliation: AstraZeneca AB

• Name: Eva Augurell
• Affiliation: AstraZeneca AB

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

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

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

Intervention(s)

Product Name: Tralokinumab
Product Code: CAT-354
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

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 of tralokinumab.

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

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 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.

Timepoint(s) of evaluation of this end point: Week 0 to Week 52 (except PK and ADA, 0 to Week 72 weeks)

Secondary ID(s)

D2210C00008

Source(s) of Monetary Support

AstraZeneca AB

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 07/04/2018
• Date Completed: 21/09/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-005615-27/results