Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00267709
• Date of registration: 19/12/2005
• Prospective Registration: No
• Primary sponsor: Facet Biotech
• Public title: Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
• Scientific title: A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease
• Date of first enrolment: February 2005
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00267709
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18-70 years old

- Diagnosis of Crohn's disease with fistula

- Test negative for Clostridium difficile within 3 weeks

- Signed informed consent, including permission to use protected health information.

Exclusion Criteria:

- History of lymphoproliferative disorder or prior malignancy within 5 years or current
malignancy

- Pregnant or nursing

- HIV, Hepatitis B or Hepatitis C infection

- Presence of obstructive symptoms, confirmed by endoscopy, within 6 months

- Likely to require surgery in the next 6 months

- Serious or active infections within 1 year

- Active infections that require antibiotic therapy

- Serious infections that require IV antibiotics or hospitalization within 8 weeks

- Started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-ASA), antibiotics,
probiotics, or topical therapies for Crohn's within 2 weeks

- Had increased dose of corticosteroids within 2 weeks

- Received a live vaccine within 6 weeks

- Received any monoclonal antibodies or investigational agents within 3 months

- Received cyclosporine or tacrolimus (FK506) within 4 weeks

- Dose change or discontinuation of 6-mercaptopurine, azathioprine, or methotrexate
within 4 weeks

- Significant organ dysfunction

- History of lymphoproliferative disorder

- History of tuberculosis, mycobacterial infection, or positive chest x-ray

- History of thrombophlebitis or pulmonary embolus

- History of immune deficiency or autoimmune disorders (other than Crohn's disease)

- History of seizure with subtherapeutic levels of anticonvulsive medication within one
week



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Visilizumab

Primary Outcome(s)

Clinical response, defined as external closure of at least 50% of perianal fistulas, without an accompanying increase in dose of concomitant medications, the addition of new medications, or Crohn's Disease-related surgery.

Secondary Outcome(s)

Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.

Secondary ID(s)

291-411

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PDL BioPharma, Inc.