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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Fistulizing Crohn's Disease

Intervention / Treatment
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* Drug: DLX105
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DLX105<br>DLX105 local injection into the identified fistula(s) | Drug: DLX105<br>* 10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.<br>|
| Placebo Comparator: Placebo Injection<br> | Drug: Placebo<br>* Placebo injections are administered over the treatment period of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response | Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression | Day 29 and Day 43 after randomization | 
| Perianal Disease Activity Index (PDAI) Score | Evaluate the efficacy with completion of PDAI at the given visits. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive management, Fistula, Crohn's Disease, local administration, non-invasive