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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Delenex Therapeutics AG
ClinicalTrials.gov Identifier:
NCT01624376
First received: June 14, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Fistulizing Crohn's Disease
Drug: DLX105
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Delenex Therapeutics AG:

Primary Outcome Measures:
  • Local Tolerability [ Time Frame: each study visit after randomization over a period of 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 29 and Day 43 after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 29 and Day 43 after randomization ] [ Designated as safety issue: No ]
    Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression

  • Perianal Disease Activity Index (PDAI) Score [ Time Frame: Baseline, Day 15, Day 29, Day 43 after randomization ] [ Designated as safety issue: No ]
    Evaluate the efficacy with completion of PDAI at the given visits.

  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624376

Locations
Switzerland
University Hospital
Zürich, Switzerland
Sponsors and Collaborators
Delenex Therapeutics AG
  More Information

No publications provided

Responsible Party: Delenex Therapeutics AG
ClinicalTrials.gov Identifier: NCT01624376     History of Changes
Other Study ID Numbers: DLX105-004-001-001
Study First Received: June 14, 2012
Last Updated: February 3, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Delenex Therapeutics AG:
non-invasive management
Fistula
Crohn's Disease
local administration
non-invasive

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 22, 2014