drugset / Trial / NCT01624376
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2012-06
- Primary completion
- 2013-02
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DLX105 | Protein / enzyme biologic | 10 mg | Other |