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A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (STRATOS2)

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ClinicalTrials.gov Identifier: NCT02194699
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 β2-Agonist

Condition or disease Intervention/treatment Phase
Uncontrolled Asthma Biological: Experimental: Tralokinumab Other: Placebo Phase 3

Detailed Description:
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. Approximately 770 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 858 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 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 β2-Agonist
Actual Study Start Date : October 30, 2014
Primary Completion Date : May 10, 2017
Study Completion Date : September 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tralokinumab
Tralokinumab subcutaneous injection
Biological: Experimental: Tralokinumab
Tralokinumab subcutaneous injection
Placebo Comparator: Placebo
Placebo subcutaneous injection
Other: Placebo
Placebo subcutaneous injection



Primary Outcome Measures :
  1. Asthma exacerbation rate reduction [ Time Frame: Week 0 to Week 52 ]
    To evaluate the effect of tralokinumab 300 mg administered every 2 weeks 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 β2-agonist


Secondary Outcome Measures :
  1. Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator forced expiratory volume in 1 second [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab with regards to lung function

  2. Change from baseline to Week 52 in daily asthma symptom score [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab with regards to asthma symptoms

  3. Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older total score [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab with regards to asthma specific health-related quality of life

  4. Change from baseline to Week 52 in Asthma Control Questionnaire-6 defined asthma control [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab with regards to Asthma Control Questionnaire-6 defined asthma control

  5. Annualised asthma exacerbation rate that is associated with an ER or urgent care visit, or a hospitalization [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to emergency room and urgent care visits and hospitalizations due to asthma

  6. European Quality of Life - 5 Dimension 5 Level Daily Living Questionnaire [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to health related quality of life

  7. Rescue medication use [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to asthma symptoms and asthma control as measured by rescue medication use

  8. Home peak expiratory flow (morning and evening) [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to asthma symptoms and asthma control as measured by home peak expiratory flow

  9. Night-time awakening due to asthma [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to asthma symptoms and asthma control as measured by night-time awakenings due to asthma

  10. Time to first asthma exacerbation [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to asthma exacerbations as measured by time to first asthma exacerbation

  11. Proportion of subjects with ≥1 asthma exacerbation [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to asthma exacerbations as measured by the proportion of subjects with at least one asthma exacerbation

  12. Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to productivity loss due to asthma

  13. Asthma specific resource utilization [ Time Frame: Week 0 to Week 52 ]
    To assess the effect of tralokinumab compared with placebo with regards to health care resource utilization

  14. Pharmacokinetic parameters (Ctrough at steady state) [ Time Frame: Week 0 to Week 72 ]
    To evaluate the pharmacokinetics of tralokinumab

  15. Incidence rate of positive anti-drug antibodies including the characterization of their neutralizing potential [ Time Frame: Week 0 to Week 72 ]
    To evaluate the immunogenicity of tralokinumab


Other Outcome Measures:
  1. Safety and Tolerability of tralokinumab assessed by the reporting of adverse events/serious adverse events and assessments for physical [ Time Frame: Week 0 to Week 72 ]
    To evaluate the safety and tolerability tralokinumab



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194699


  Show 235 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Christopher Brightling, MD Institute for Lung Health, United Kingdom

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02194699     History of Changes
Other Study ID Numbers: D2210C00008
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is commercially sensitive information.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs