A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma | Completed
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma
Health Conditions
  • Asthma
Completed
Recruitment Status
NCT01402986
Primary Trial ID Number
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
Primary Outcome Measures
  • Asthma Exacerbation; 52 weeks
Secondary Outcome Measures
  • safety and tolerability; Day 1 - Week 75; Pharmacokinetics of tralokinumab; Day 1 - Week 75; Effect of tralokinumab on pulmonary function as measured by FEV1, FEV6, FVC, IC, and PEF; Day 1 - Week 52; Patient reported outcomes; Week 2 - Week 75
Research Question
  • 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
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; Argentina; Brazil; Canada; Chile; Czech Republic; France; Germany; Japan; Korea, Republic of; Mexico; Philippines; Poland; Russian Federation; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • 1. Age 18-75 years
  • 2. Body mass index (BMI) between 16-40 kg/m2 at Visit 1.
  • 3. Uncontrolled severe asthma
  • 4. A chest x-ray with no abnormality
  • 5. Females of childbearing potential who are sexually active with a nonsterilized male
  • partner must use highly effective contraception from Day1
  • 6. Nonsterilized males or sterilized males who are ≤ 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:
  • 1. 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.
  • 2. Pregnant or breastfeeding women
  • 3. Any other respiratory disease
  • 4. Previously taken tralokinumab (the study drug)
  • 5. Current smoker or a history of smoking which would be more than 1 pack per day for 10
  • years
  • 6. Known immune deficiency
  • 7. History of cancer
  • 8. Hepatitis B, C or HIV
  • 9. Any disease which may cause complications whilst taking the study drug
Participant Exclusion Criteria
  • Inclusion Criteria:
  • 1. Age 18-75 years
  • 2. Body mass index (BMI) between 16-40 kg/m2 at Visit 1.
  • 3. Uncontrolled severe asthma
  • 4. A chest x-ray with no abnormality
  • 5. Females of childbearing potential who are sexually active with a nonsterilized male
  • partner must use highly effective contraception from Day1
  • 6. Nonsterilized males or sterilized males who are ≤ 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:
  • 1. 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.
  • 2. Pregnant or breastfeeding women
  • 3. Any other respiratory disease
  • 4. Previously taken tralokinumab (the study drug)
  • 5. Current smoker or a history of smoking which would be more than 1 pack per day for 10
  • years
  • 6. Known immune deficiency
  • 7. History of cancer
  • 8. Hepatitis B, C or HIV
  • 9. Any disease which may cause complications whilst taking the study drug
Interventions
Drug; Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the immunoglobulin G4 (IgG4) subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; [Cohort 1, Cohort 2]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma
Secondary Trial Identifying Number
2011-001360-21
Website
Sorry, this information is not available
Study Funded By
MedImmune LLC
Funder Type
Sorry, this information is not available
Study Sponsored By
MedImmune LLC
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

21 Jul 2011

Last Updated

20 Mar 2014

Date Record Refreshed on UKCTG

31 Jul 2015