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

NCT ID: NCT00307827

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-11-30

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.

Detailed Description

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

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Visilizumab low dose level

Group Type: EXPERIMENTAL

Visilizumab

Intervention Type: DRUG

Visilizumab administered intravenously once per day for two days

Arm 2

Visilizumab middle dose level

Group Type: EXPERIMENTAL

Visilizumab

Intervention Type: DRUG

Visilizumab administered intravenously once per day for two days

Arm 3

Visilizumab high dose level

Group Type: EXPERIMENTAL

Visilizumab

Intervention Type: DRUG

Visilizumab administered intravenously once per day for two days

Interventions

Visilizumab

Visilizumab administered intravenously once per day for two days

Intervention Type: DRUG

Other Intervention Names

Nuvion®; HuM291

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihail Obrocea, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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

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

Countries

United States; Canada; Croatia; Italy; Russia; Spain

Other Identifiers

2005-003482-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

291-418

Identifier Type: -

Identifier Source: org_study_id