Fistulizing Crohn's Disease
Conditions
Keywords
non-invasive management, Fistula, Crohn's Disease, local administration, non-invasive
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).
Interventions
DRUGDLX105
10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
DRUGPlacebo
Placebo injections are administered over the treatment period of 4 weeks.
Sponsors
Delenex Therapeutics AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tolerability | 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. |
| Reduction of Number of draining fistulas | 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
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 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 |
| Perianal Disease Activity Index (PDAI) Score | Baseline, Day 15, Day 29, Day 43 after randomization | Evaluate the efficacy with completion of PDAI at the given visits. |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerapility | each study visit over a period of 6 weeks after randomization | — |
Countries
Switzerland
Outcome results
None listed