A Pilot Study of FFP104 in Subjects With Crohn's Disease
- Registration Number
- NCT02465944
- Lead Sponsor
- Fast Forward Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo FFP104 - 2.5 mg/kg FFP104 FFP104 FFP104 - 5.0 mg/kg FFP104 FFP104
- Primary Outcome Measures
Name Time Method Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments Up to 84 days
- Secondary Outcome Measures
Name Time Method 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 Health outcome measures that will be used are Short Form 36 (SF36), the EuroQol EQ-5D-5L and the Work Productivity and Activity Impairment Questionnaire Crohn's Disease (WPAI-CD)
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
Trial Locations
- Locations (2)
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands