NCT00279422
Terminated
Phase 2
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Facet Biotech0 sites127 target enrollmentStarted: February 2006Last updated:
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Facet Biotech
- Enrollment
- 127
Overview
Brief Summary
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Detailed Description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
placebo
Placebo Comparator
Intervention: visilizumab (Drug)
visilizumab
Experimental
Intervention: visilizumab (Drug)
Investigators
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