Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

This study has been terminated.
(company decision based on other studies)
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00279435
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, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Enrollment: 25
Study Start Date: August 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:

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 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.
  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279435

  Show 39 Study Locations
Sponsors and Collaborators
Facet Biotech
PDL BioPharma, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00279435     History of Changes
Other Study ID Numbers: 291-417
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 July 28, 2014