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

Primary Purpose

Fistulizing Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
DLX105
Placebo
Sponsored by
Delenex Therapeutics AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fistulizing Crohn's Disease focused on measuring non-invasive management, Fistula, Crohn's Disease, local administration, non-invasive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DLX105

Placebo Injection

Arm Description

DLX105 local injection into the identified fistula(s)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Complete Response
Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression
Perianal Disease Activity Index (PDAI) Score
Evaluate the efficacy with completion of PDAI at the given visits.
Number of Participants with Adverse Events as a Measure of Safety and Tolerapility

Full Information

First Posted
June 14, 2012
Last Updated
February 3, 2014
Sponsor
Delenex Therapeutics AG
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1. Study Identification

Unique Protocol Identification Number
NCT01624376
Brief Title
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Delenex Therapeutics AG

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistulizing Crohn's Disease
Keywords
non-invasive management, Fistula, Crohn's Disease, local administration, non-invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLX105
Arm Type
Active Comparator
Arm Description
DLX105 local injection into the identified fistula(s)
Arm Title
Placebo Injection
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DLX105
Intervention Description
10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injections are administered over the treatment period of 4 weeks.
Primary Outcome Measure Information:
Title
Local Tolerability
Description
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.
Time Frame
each study visit after randomization over a period of 4 weeks
Title
Reduction of Number of draining fistulas
Description
Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
Time Frame
Day 29 and Day 43 after randomization
Secondary Outcome Measure Information:
Title
Complete Response
Description
Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression
Time Frame
Day 29 and Day 43 after randomization
Title
Perianal Disease Activity Index (PDAI) Score
Description
Evaluate the efficacy with completion of PDAI at the given visits.
Time Frame
Baseline, Day 15, Day 29, Day 43 after randomization
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerapility
Time Frame
each study visit over a period of 6 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

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

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