Project
GA28950/Hickory
Automatically Closed · 2015 until 2017
Borovicka Jan, Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Automatically Closed
Start Date
2015
End Date
2017
Financing
Industry
Study Design
This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the safety, efficacy and tolerability of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of moderately to severely active UC (Figure 1).
Disease severity will be measured using the Mayo Clinic Score (MCS; see Appendix B), which is the current regulatory authorityapprovable outcome measure for drug development in UC. The study population consists of patients with moderately to severely active UC (defined as Mayo Clinic Score [MCS] of 6 12 and a centrally read endoscopy subscore of 2) and continuous disease activity a minimum of 20 cm from the anal verge.
Brief description/objective
PHASE III, BLINDED, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNF INHIBITORS