NCT01624376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

8 months

First QC Date

June 14, 2012

Last Update Submit

February 3, 2014

Conditions

Fistulizing Crohn's Disease

Keywords

non-invasive managementFistulaCrohn's Diseaselocal administrationnon-invasive

Outcome Measures

Primary Outcomes (2)

  • 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.

    each study visit after randomization over a period of 4 weeks

  • 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.

    Day 29 and Day 43 after randomization

Secondary Outcomes (3)

  • Complete Response

    Day 29 and Day 43 after randomization

  • Perianal Disease Activity Index (PDAI) Score

    Baseline, Day 15, Day 29, Day 43 after randomization

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerapility

    each study visit over a period of 6 weeks after randomization

Study Arms (2)

DLX105

ACTIVE COMPARATOR

DLX105 local injection into the identified fistula(s)

Drug: DLX105

Placebo Injection

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DLX105DRUG

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

DLX105
PlaceboDRUG

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

Placebo Injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Zurich, Switzerland

Location

MeSH Terms

Conditions

FistulaCrohn Disease

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 20, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

CH(1)