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

Phase 2

Completed

• Conditions: Fistulizing Crohn's Disease
• Interventions: Drug: Placebo; Drug: DLX105

• Registration Number: NCT01624376
• Lead Sponsor: Delenex Therapeutics AG

Brief 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).

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-20
• Primary Completion: 2013-02
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Diagnosis of Crohn' Disease
• Single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration.
• TNF-blocker naive patients or patients who are primary or secondary anti-TNF non-responders

Exclusion Criteria

• CDAI greater than 450
• ongoing treatment with TNF-blockers (duration of wash-out prior to randomization is 8 weeks)
• Active abscess formation within fistula
• Abdominal or anorectal surgery within the last 4 weeks prior to randomization
• Known immunosuppression
• Infections, sepsis
• Positive Test for hepatitis B or C and HIV
• Patients who had life vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
• Active liver disease with ALT and/or AST greater than 3x upper limit of normal
• Any severe, progressive or uncontrolled medical condition that in judgment of investigator prevents the patient from participating in the study.
• History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
• Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive B-hCG laboratory test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Injection	Placebo	-
DLX105	DLX105	DLX105 local injection into the identified fistula(s)

Primary Outcome Measures

Name	Time	Method
Local Tolerability	each study visit after randomization over a period of 4 weeks	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	Day 29 and Day 43 after randomization	Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.

Secondary Outcome Measures

Name	Time	Method
Complete Response	Day 29 and Day 43 after randomization	Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression
Perianal Disease Activity Index (PDAI) Score	Baseline, Day 15, Day 29, Day 43 after randomization	Evaluate the efficacy with completion of PDAI at the given visits.
Number of Participants with Adverse Events as a Measure of Safety and Tolerapility	each study visit over a period of 6 weeks after randomization

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Zürich, Switzerland