A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis
Study identifier:CD-RI-CAT-354-1066
ClinicalTrials.gov identifier:NCT01629667
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis
Medical condition
Idiopathic Pulmonary Fibrosis
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
409
Study type
Interventional
Age
50 Years - 79 Years
Date
Study Start Date: 01 Oct 2012
Primary Completion Date: 01 May 2015
Study Completion Date: 01 Jan 2016
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2017 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tralokinumab 400 milligram (mg) Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks. | Biological/Vaccine: Tralokinumab Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks. |
| Experimental: Tralokinumab 800 mg Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks. | Biological/Vaccine: Tralokinumab Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks. |
| Placebo Comparator: Placebo Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks. | Other: Placebo Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks. |
Contacts
Investigators
Principal Investigator
Joseph Parker
MedImmune, LLC
