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

Fistulizing Crohn's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624376
• Other study ID #: DLX105-004-001-001
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2012
• Last updated: February 3, 2014
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Delenex Therapeutics AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Fistulizing Crohn's Disease

Intervention

Drug:
• DLX105
10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
• Placebo
Placebo injections are administered over the treatment period of 4 weeks.

Locations

Country	Name	City	State
Switzerland	University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Delenex Therapeutics AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerapility		each study visit over a period of 6 weeks after randomization	Yes