Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00267722
• Date of registration: 19/12/2005
• Prospective Registration: No
• Primary sponsor: Facet Biotech
• Public title: Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease
• Scientific title: A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease
• Date of first enrolment: February 2005
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00267722
• 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 moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn's
disease, defined as Crohn's Disease Activity Index greater than or equal to 250,
C-reactive protein greater than or equal to upper limit of normal, and endoscopic
evidence of moderate-to-severe active inflammatory disease

- 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

- Serious infections within 12 months

- Active infections that require antibiotic therapy

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

- Serious infections that required IV antibiotic therapy or hospitalization within 8
weeks

- Increase dose of corticosteroid medication 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 from 6-mercaptopurine, azathioprine, or methotrexate
within 4 weeks

- Significant organ dysfunction

- Likely to require surgery in the next 6 months

- History of lymphoproliferative disorder

- History of tuberculosis or mycobacteria infection or positive chest x-ray

- History of thrombophlebitis or pulmonary embolus

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

- History of subtherapeutic blood levels of anticonvulsive medications within 1 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 a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.

Secondary Outcome(s)

Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.

Secondary ID(s)

291-412

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PDL BioPharma, Inc.