Completed
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.
What is being tested
DLX105
+ Placebo
Drug
Who is being recruted
Crohn Disease+6
+ Digestive System Diseases
+ Fistula
From 18 to 65 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: June 2012
Summary
Principal SponsorDelenex Therapeutics AG
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2012
Actual date on which the first participant was enrolled.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 TitleA 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.
Principal SponsorDelenex Therapeutics AG
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Crohn DiseaseDigestive System DiseasesFistulaGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesPathological Conditions, Anatomical
Criteria
3 inclusion criteria required to participate
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
12 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorDLX105 local injection into the identified fistula(s)
Group II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center