Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

This study has been terminated.
(Study Canceled)
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00307827
First received: March 24, 2006
Last updated: April 26, 2012
Last verified: April 2012
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1). [ Time Frame: Day 45 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of subjects in the three visilizumab dose groups [ Time Frame: During the course of the study ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Visilizumab low dose level
Drug: Visilizumab
Visilizumab administered intravenously once per day for two days
Other Name: Nuvion®; HuM291
Experimental: Arm 2
Visilizumab middle dose level
Drug: Visilizumab
Visilizumab administered intravenously once per day for two days
Other Name: Nuvion®; HuM291
Experimental: Arm 3
Visilizumab high dose level
Drug: Visilizumab
Visilizumab administered intravenously once per day for two days
Other Name: Nuvion®; HuM291

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
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: NCT00307827

Locations
United States, Georgia
Site Reference ID/Investigator# 71894
Savannah, Georgia, United States, 31405
United States, Massachusetts
Site Reference ID/Investigator# 71897
Worcester, Massachusetts, United States, 01655
United States, New York
Site Reference ID/Investigator# 71913
Manhasset, New York, United States, 11030
United States, North Carolina
Site Reference ID/Investigator# 71895
Chapel Hill, North Carolina, United States, 27599-7032
United States, Ohio
Site Reference ID/Investigator# 71896
Cleveland, Ohio, United States, 44106-5066
Canada
Site Reference ID/Investigator# 71875
Hamilton, Canada, L8N 3Z5
Site Reference ID/Investigator# 71873
Winnipeg, Canada, R3A 1R9
Croatia
Site Reference ID/Investigator# 72338
Osijek, Croatia, 31 000
Site Reference ID/Investigator# 72334
Zagreb, Croatia, 10000
Italy
Site Reference ID/Investigator# 72345
Bologna, Italy, 40138
Russian Federation
Site Reference ID/Investigator# 72314
Moscow, Russian Federation, 111123
Site Reference ID/Investigator# 71953
Nizhny-Novgorod, Russian Federation, 603126
Site Reference ID/Investigator# 72315
St. Petersburg, Russian Federation, 196247
Site Reference ID/Investigator# 72342
St. Petersburg, Russian Federation
Spain
Site Reference ID/Investigator# 72368
Badalona - Barcelona, Spain, 08916
Site Reference ID/Investigator# 72366
Majadahonda (Madrid), Spain, 28222
Sponsors and Collaborators
Abbott
Investigators
Study Director: Mihail Obrocea, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00307827     History of Changes
Other Study ID Numbers: 291-418, 2005-003482-17
Study First Received: March 24, 2006
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Steroid-Refractory
IVSR-UC
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 August 19, 2014