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

Trial Source

There is no location for this trial

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

Health Conditions
  • Asthma
Unfortunately contact details are not available for this trial.
Primary Contact Details
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
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 participants with severe asthma
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Tralokinumab

Study Arm Groups : Cohort 1, Cohort 2

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Manchester
Leicester
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Brazil, Canada, Chile, Czech Republic, France, Germany, Japan, Korea, Republic of, Mexico, Philippines, Poland, Russian Federation, Spain, United Kingdom
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 Assigned

21 Jul 2011

Last Updated

20 Mar 2014