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

Sponsor

Delenex Therapeutics AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01624376

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fistulizing Crohn's Disease	Drug: DLX105 Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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