A Safety and Efficacy Study of Tralokinumab in Adults With Asthma | Completed
A Safety and Efficacy Study of Tral... | Completed
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Asthma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01402986
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.
Research Details
  • Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Other : Placebo Q2W, Biological : Tralokinumab 300 mg, Q2W, Other : Placebo, Q2/4W, Biological : Tralokinumab 300 mg, Q2/4W

Study Arm Groups : Placebo, Q2W - Cohort 1, Tralokinumab 300 mg, Q2W - Cohort 1, Placebo, Q2/4W - Cohort 2, Tralokinumab 300 mg, Q2/4W - Cohort 2

Intervention Type
See Interventions above
Primary Outcome Measures
    Annual Asthma Exacerbation Rate (AER); Week 1 up to Week 53
Secondary Outcome Measures
    Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53; Baseline and Week 53; Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53; Baseline and Week 53; Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53; Baseline and Week 53; Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53; Baseline and Week 53; Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53; Baseline and Week 53; Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home; Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53); Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home; Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53); Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53; Baseline and Week 53; Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53; Baseline and Week 53; Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53; Week 53; Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53; Baseline and Week 53; Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53; Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53); Change From Baseline in Rescue Medication Use at Week 53; Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs); Baseline and Week 75; Observed Serum Tralokinumab Concentration at Week 53; Week 53; Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab; Baseline and Week 75; Severe Annual Asthma Exacerbation Rate (AER); Week 1 up to Week 53; Time to First Exacerbation Through Week 53; Week 1 up to Week 53; Time to First Severe Exacerbation Through Week 53; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year; Week 1 up to Week 53; Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin; Week 1 up to Week 53; Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility; Week 1 up to Week 53; Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status; Week 1 up to Week 53; Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count; Week 1 up to Week 53; Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups; Week 1 up to Week 53; Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups; Week 1 up to Week 53; Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status; Week 1 up to Week 53; Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use; Week 1 up to Week 53; Change From Baseline in Percentage of Nighttime Awakening at Week 53; Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53); Change From Baseline in Overall Activity Limitations at Week 53; Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53); Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53; Baseline and Week 53; Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53; Baseline and Week 53; Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53; Baseline and Week 53; Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53; Baseline and Week 53; Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home; Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53); Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home; Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Age 18-75 years

    - Body mass index (BMI) between 16-40 kilogram per square meter (kg/m^2) at Visit 1

    - Uncontrolled severe asthma

    - A chest x-ray with no abnormality

    - Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1

    - Non-sterilized males or sterilized males who are less than or equal to (=<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception

    Exclusion Criteria:

    - Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals

    - Pregnant or breastfeeding women

    - Any other respiratory disease

    - Previously taken tralokinumab (the study drug)

    - Current smoker or a history of smoking which would be more than 1 pack per day for 10 years

    - Known immune deficiency

    - History of cancer

    - Hepatitis B, C or Human Immuno-deficiency Virus (HIV)

    - Any disease which may cause complications whilst taking the study drug.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
Uni Hospital Leicester
Leicester
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Canada, Chile, Czech Republic, France, Germany, Japan, Korea, Republic of, Mexico, Philippines, Poland, Russian Federation, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CD-RI-CAT-354-1049
Sponsor(s)
MedImmune LLC
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Jun 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

21 Jul 2011

Date updated in source

03 Mar 2017