At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 147 enrolled
Drug / intervention
tralokinumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating tralokinumab and placebo for Ulcerative Colitis. Completed, enrolled 147 participants across 28 sites in 6 countries.
Detailed Summary
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesCzechia, France, Germany, Italy, Poland, United Kingdom
CollaboratorsMedImmune Ltd
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMar 2012
Primary CompletionMar 2013
Study CompletionJun 2013
TodayJul 2026
First PostedDec 1, 2011
Enrollment StartMar 1, 2012
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.6 years ago
Interventions
tralokinumabdrug
2 sc injections of every 2 weeks for 12 weeks.
placebodrug
2 sc injections of every 2 weeks for 12 weeks.