Status:
TERMINATED
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
Lead Sponsor:
Facet Biotech
Collaborating Sponsors:
PDL BioPharma, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
Detailed Description
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study. PDL...
Eligibility Criteria
Inclusion
- Males and females, 18 years of age or older.
- Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study).
- Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (IVSR-UC) disease to visilizumab or placebo.
- Symptomatic worsening (ie, an increase of ≥3 points in MTWSI score) from the subject's best response on the parent study, an MTWSI score of ≥9, sustained for at least 2 assessments performed at least 1 week apart, and a confirmatory MTWSI ≥8 within 1 day prior to randomization.
- CD4\^+ T-cell count ≥ 200 cells/mcL at screening for this protocol, or ≥ 80% of the subject's screening baseline count prior to enrollment on the parent study.
- Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization.
- 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
- UC requiring immediate surgical, endoscopic, or radiologic interventions.
- White blood cell count less than 2.5 x 10\^3/mcL; platelet count less than 150 x 10\^3/mcL; or hemoglobin less than 8 g/dL.
- Active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past 12 months.
- Live vaccination within 6 weeks prior to randomization.
- Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality, history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent.
- History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated within the past five years.
- Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
- Pregnancy or nursing.
- Treatment with any other UC salvage drugs (including but not limited to infliximab or another anti-TNF-a drug, cyclosporine, tacrolimus \[FK506\], adalimumab, thalidomide, or another experimental agent), or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study.
- Treatment with any other investigational drug or therapy within 60 days prior to randomization.
- Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures.
- Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00279435
Start Date
August 1 2006
End Date
August 1 2007
Last Update
March 12 2012
Active Locations (39)
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1
Atlanta, Georgia, United States, 30342
2
Louisville, Kentucky, United States, 40202
3
Boston, Massachusetts, United States, 02118
4
Worcester, Massachusetts, United States, 01655