NCT01624376

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Delenex Therapeutics AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Fistulizing Crohn's Disease

Interventions

Type	Name	Description
DRUG	DLX105	10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
DRUG	Placebo	Placebo injections are administered over the treatment period of 4 weeks.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-02-01
• Completion: 2013-08-01
• First posted: 2012-06-20
• Last updated: 2014-02-04

Locations

1 site across 1 country: Switzerland