A Safety and Efficacy Study of Tralokinumab in Adults with Asthma
Study identifier:CD-RI-CAT-354-1049
ClinicalTrials.gov identifier:NCT01402986
EudraCT identifier:2011-001360-21
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
689
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Aug 2011
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Feb 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2017 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo, Q2W - Cohort 1 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. | Other: Placebo Q2W Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. |
| Experimental: Tralokinumab 300 mg, Q2W - Cohort 1 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. | Biological/Vaccine: Tralokinumab 300 mg, Q2W Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks. Other Name: CAT-354 |
| Placebo Comparator: Placebo, Q2/4W - Cohort 2 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses. | Other: Placebo, Q2/4W Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses. |
| Experimental: Tralokinumab 300 mg, Q2/4W - Cohort 2 Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses. | Biological/Vaccine: Tralokinumab 300 mg, Q2/4W Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses. Other Name: CAT-354 |
Contacts
Investigators
Principal Investigator
Edward Piper
Sponsor
