Status:
TERMINATED
Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
Lead Sponsor:
Abbott
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 eval...
Detailed Description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00307827
Start Date
April 1 2006
End Date
November 1 2007
Last Update
April 27 2012
Active Locations (16)
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1
Site Reference ID/Investigator# 71894
Savannah, Georgia, United States, 31405
2
Site Reference ID/Investigator# 71897
Worcester, Massachusetts, United States, 01655
3
Site Reference ID/Investigator# 71913
Manhasset, New York, United States, 11030
4
Site Reference ID/Investigator# 71895
Chapel Hill, North Carolina, United States, 27599-7032