Clinical trial NCT01624376: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fistulizing Crohn's Disease
Keywords: non-invasive management
Fistula
Crohn's Disease
local administration
non-invasive
Lead sponsor: Delenex Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Local Tolerability
timeFrame: each study visit after randomization over a period of 4 weeks
measure: Reduction of Number of draining fistulas
timeFrame: Day 29 and Day 43 after randomization
Secondary outcomes:
measure: Complete Response
timeFrame: Day 29 and Day 43 after randomization
measure: Perianal Disease Activity Index (PDAI) Score
timeFrame: Baseline, Day 15, Day 29, Day 43 after randomization
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerapility
timeFrame: each study visit over a period of 6 weeks after randomization
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital
Study officials:
References: