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Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
This study has been terminated.
Sponsored by: PDL BioPharma, Inc.
Information provided by: PDL BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT00307827
  Purpose

The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.


Condition Intervention Phase
Ulcerative Colitis
Drug: Visilizumab (Nuvion®; HuM291)
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Visilizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

Further study details as provided by PDL BioPharma, Inc.:

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: February 2010
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:

Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:

  • Males and females, 18 years of age or older.
  • Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent.
  • Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) ≥ 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 at screening.
  • Negative Clostridium difficile test within 10 days prior to randomization.
  • Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.

Exclusion Criteria:

Subjects will be ineligible for this study if they meet any one of the following criteria:

  • UC requiring immediate 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 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-TNF-a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a 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.
  • Unwilling or unable to discontinue all UC drugs, except glucocorticoids and oral 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: NCT00307827

  Show 40 Study Locations
Sponsors and Collaborators
PDL BioPharma, Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 291-418
Study First Received: March 24, 2006
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00307827  
Health Authority: United States: Food and Drug Administration

Keywords provided by PDL BioPharma, Inc.:
Steroid-Refractory, IVSR-UC, Ulcerative Colitis

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009