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

NCT ID: NCT01624376

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-08-31

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).

Conditions

Fistulizing Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DLX105

DLX105 local injection into the identified fistula(s)

Group Type: ACTIVE_COMPARATOR

DLX105

Intervention Type: DRUG

10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.

Placebo Injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo injections are administered over the treatment period of 4 weeks.

Interventions

DLX105

10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.

Intervention Type: DRUG

Placebo

Placebo injections are administered over the treatment period of 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delenex Therapeutics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

DLX105-004-001-001

Identifier Type: -

Identifier Source: org_study_id