Study identifier:CD-RI-CAT-354-1049
ClinicalTrials.gov identifier:NCT01402986
EudraCT identifier:2011-001360-21
CTIS identifier:N/A
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma
asthma
Phase 2
No
-
All
689
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2017 by MedImmune, LLC
MedImmune, LLC
-
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 |