A Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects With Moderate to Severely Active Crohn's Disease

简要总结

主要结局

次要结局

• Change from baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS)(Day 42)
• Percent change from baseline in C-Reactive Protein (CRP) levels(Day 7, 14, 28, 42 and 84)
• To evaluate changes from baseline in serum FFP104 levels(up to 84 days)
• Proportion of subjects achieving clinical response (decrease of Crohn's Disease Activity Index (CDAI) score by ≥100 points from baseline)(Days 0, 7, 14, 28, 42 and 84)
• Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)(Day 42)
• Change from baseline in health outcome measures(Day 42)
• Proportion of subjects achieving clinical remission (attainment of absolute CDAI score of 150 points or less from baseline)(Days 0, 7, 14, 28, 42 and 84)
• Proportion of subjects achieving partial response (decrease of CDAI score by >70 points from baseline)(Days 0, 7, 14, 28, 42 and 84)
• Difference in CDAI score between FFP104 treated subjects and placebo subjects in each arm of the study(Days 0, 7, 14, 28, 42 and 84)
• Percent change from baseline in faecal calprotectin level(Day 42)
• Time to response (decrease in CDAI score by >100 points)(Days 0, 7, 14, 28, 42 and 84)
• Time to partial response (decrease of CDAI score by >70 points)(Days 0, 7, 14, 28, 42 and 84)
• Change from baseline in gut tissue organisation (histology)(Day 42)
• To evaluate changes in lymphocyte sub-populations in peripheral blood(Day 0, 14 and 42)