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

Delenex Therapeutics

Status and phase: Completed; Phase 2

Conditions: Fistulizing Crohn's Disease

Treatments: Drug: DLX105; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624376

DLX105-004-001-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

DLX105

Active Comparator group

Description:

DLX105 local injection into the identified fistula(s)

Treatment:

Drug: DLX105

Placebo Injection

Placebo Comparator group

Treatment:

Drug: Placebo