A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

This study has been terminated.
(DMC recommendation, no efficacy)
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00279422
First received: January 17, 2006
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.


Condition Intervention Phase
Ulcerative Colitis
Drug: visilizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Enrollment: 127
Study Start Date: February 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: visilizumab
Experimental: visilizumab Drug: visilizumab

Detailed Description:

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 years of age or older.
  • Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
  • Severe active disease, as defined by a Modified Truelove & Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 11 at consent, with a confirmatory MTWSI ≥ 10 on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day prior to randomization.
  • Mayo score ≥ 10 and Mayo mucosal subscore ≥ 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
  • Adequate contraception from the day of consent through 3 months after the last dose of study drug.
  • Negative serum pregnancy test.
  • Negative Clostridium difficile test.
  • Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.

Exclusion Criteria:

  • UC requiring immediate intervention or toxic megacolon requiring imminent intervention.
  • History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
  • Presence of Ileostomy.
  • White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin level less than 8 g/dL.
  • Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
  • Live vaccination within 6 weeks prior to randomization.
  • Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
  • History of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent.
  • History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
  • Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
  • Pregnancy or nursing.
  • Treatment with a first dose of infliximab or another anti-tumor necrosis factor (TNF)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α drug within 2 weeks of randomization.
  • Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
  • Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two exclusion criteria above.
  • Unable or willing to discontinue any UC drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA, immediately prior to randomization.
  • Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
  • Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279422

  Show 70 Study Locations
Sponsors and Collaborators
Facet Biotech
PDL BioPharma, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00279422     History of Changes
Other Study ID Numbers: 291-415
Study First Received: January 17, 2006
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Intravenous, Steroid-Refractory, Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014