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.

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.

Study Overview

• Status: Completed
• Conditions: Fistulizing Crohn's Disease
• Intervention / Treatment: Drug: DLX105; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DLX105; DLX105 local injection into the identified fistula(s)	Drug: DLX105; 10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
Placebo Comparator: Placebo Injection	Drug: Placebo; Placebo injections are administered over the treatment period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Delenex Therapeutics AG

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: non-invasive; Fistula; Crohn's Disease; non-invasive management; local administration
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: DLX105-004-001-001