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

Stopped early · Phase 2

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00307827

Run by

Abbott

People needed

38

Starts

2006-04-01

Expected to finish

2007-11-01

Last updated by the study team

2012-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 71873 — Winnipeg, Canada
• Site Reference ID/Investigator# 72338 — Osijek, Croatia
• Site Reference ID/Investigator# 72334 — Zagreb, Croatia
• Site Reference ID/Investigator# 72345 — Bologna, Italy
• Site Reference ID/Investigator# 72314 — Moscow, Russia
• Site Reference ID/Investigator# 71953 — Nizhny Novgorod, Russia
• Site Reference ID/Investigator# 72315 — Saint Petersburg, Russia
• Site Reference ID/Investigator# 72342 — Saint Petersburg, Russia
• Site Reference ID/Investigator# 72368 — Badalona - Barcelona, Spain
• Site Reference ID/Investigator# 72366 — Majadahonda (Madrid), Spain
• Site Reference ID/Investigator# 71894 — Savannah, Georgia, United States
• Site Reference ID/Investigator# 71897 — Worcester, Massachusetts, United States
• Site Reference ID/Investigator# 71913 — Manhasset, New York, United States
• Site Reference ID/Investigator# 71895 — Chapel Hill, North Carolina, United States
• Site Reference ID/Investigator# 71896 — Cleveland, Ohio, United States
• Site Reference ID/Investigator# 71875 — Hamilton, Canada

Full record on ClinicalTrials.gov

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