NCT02465944
Unknown
Phase 1
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
Fast Forward Pharmaceuticals2 sites in 2 countries24 target enrollmentJanuary 2016
Overview
- Phase
- Phase 1
- Intervention
- FFP104
- Conditions
- Crohn's Disease
- Sponsor
- Fast Forward Pharmaceuticals
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will be conducted to evaluate the safety, tolerability and efficacy of intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with moderate to severely active Crohn's Disease
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
FFP104 - 2.5 mg/kg
FFP104
Intervention: FFP104
FFP104 - 5.0 mg/kg
FFP104
Intervention: FFP104
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments
Time Frame: Up to 84 days
Secondary Outcomes
- 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)
Study Sites (2)
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