The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients. The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after the last study visit.
Beside investigation of the safety and tolerability of locally administered DLX105, the purpose of the study is also to evaluate the response rate and time to response of enterocutaneous fistulas following local injection of DLX105 (secondary objective).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
University Hospital
Zurich, Switzerland
Local Tolerability
Investigator and Patient will assess the local tolerability of DLX105 for each treated fistula using a 10-cm visual analogue scale (VAS) at each study visit. Changes from Baseline will be reported descriptively.
Time frame: each study visit after randomization over a period of 4 weeks
Reduction of Number of draining fistulas
Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
Time frame: Day 29 and Day 43 after randomization
Complete Response
Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression
Time frame: Day 29 and Day 43 after randomization
Perianal Disease Activity Index (PDAI) Score
Evaluate the efficacy with completion of PDAI at the given visits.
Time frame: Baseline, Day 15, Day 29, Day 43 after randomization
Number of Participants with Adverse Events as a Measure of Safety and Tolerapility
Time frame: each study visit over a period of 6 weeks after randomization
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