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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01624376
• Date of registration: 14/06/2012
• Prospective Registration: No
• Primary sponsor: Delenex Therapeutics AG
• Public title: Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
• Scientific 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.
• Date of first enrolment: June 2012
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01624376
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Switzerland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fistulizing Crohn's Disease

Intervention(s)

Drug: Placebo

Drug: DLX105

Primary Outcome(s)

Reduction of Number of draining fistulas [Time Frame: Day 29 and Day 43 after randomization]

Local Tolerability [Time Frame: each study visit after randomization over a period of 4 weeks]

Secondary Outcome(s)

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]

Perianal Disease Activity Index (PDAI) Score [Time Frame: Baseline, Day 15, Day 29, Day 43 after randomization]

Complete Response [Time Frame: Day 29 and Day 43 after randomization]

Secondary ID(s)

DLX105-004-001-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors