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Completed

NCT Number: NCT01624376

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

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.

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Key information

Conditions

Fistulizing Crohn's Disease Crohn Disease Digestive System Diseases Fistula Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital

Zurich, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DLX105

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Local Tolerability

    Time frame: 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.

  2. Reduction of Number of draining fistulas

    Time frame: 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 outcomes

  1. Complete Response

    Time frame: 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

  2. Perianal Disease Activity Index (PDAI) Score

    Time frame: Baseline, Day 15, Day 29, Day 43 after randomization

    Evaluate the efficacy with completion of PDAI at the given visits.

  3. 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

Sponsors and collaborators

Lead sponsor

Delenex Therapeutics AG

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2012
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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