Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105.|
- Local Tolerability [ Time Frame: each study visit after randomization over a period of 4 weeks ] [ Designated as safety issue: Yes ]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.
- Reduction of Number of draining fistulas [ Time Frame: Day 29 and Day 43 after randomization ] [ Designated as safety issue: No ]Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
- Complete Response [ Time Frame: Day 29 and Day 43 after randomization ] [ Designated as safety issue: No ]Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression
- Perianal Disease Activity Index (PDAI) Score [ Time Frame: Baseline, Day 15, Day 29, Day 43 after randomization ] [ Designated as safety issue: No ]Evaluate the efficacy with completion of PDAI at the given visits.
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: DLX105
DLX105 local injection into the identified fistula(s)
10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
|Placebo Comparator: Placebo Injection||
Placebo injections are administered over the treatment period of 4 weeks.
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).