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Trial record 1 of 13 for:    visilizumab
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Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307827
Recruitment Status : Terminated (Study Canceled)
First Posted : March 28, 2006
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):

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 evaluate optimal dosing.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Visilizumab Phase 2

Detailed Description:
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comparison of subjects in the three visilizumab dose groups [ Time Frame: During the course of the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307827

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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
Site Reference ID/Investigator# 71875
Hamilton, Canada, L8N 3Z5
Site Reference ID/Investigator# 71873
Winnipeg, Canada, R3A 1R9
Site Reference ID/Investigator# 72338
Osijek, Croatia, 31 000
Site Reference ID/Investigator# 72334
Zagreb, Croatia, 10000
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
Site Reference ID/Investigator# 72368
Badalona - Barcelona, Spain, 08916
Site Reference ID/Investigator# 72366
Majadahonda (Madrid), Spain, 28222
Sponsors and Collaborators
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Study Director: Mihail Obrocea, MD Abbott

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Responsible Party: Abbott Identifier: NCT00307827    
Other Study ID Numbers: 291-418
2005-003482-17 ( EudraCT Number )
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Abbott:
Ulcerative Colitis
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Immunologic Factors
Physiological Effects of Drugs