Fistulizing Crohn's Disease Clinical Trial
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.
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). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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| Withdrawn |
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