drugset / Trial / NCT01624376

Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease

NCT01624376 ↗

Phase 2 Completed 18 enrolled Delenex Therapeutics AG
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

EvaluationDrugModalityDoseRoute
Comparator DLX105 Protein / enzyme biologic 10 mg Other

Indications