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

Ulcerative Colitis Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00307827
• Other study ID #: 291-418
• Secondary ID: 2005-003482-17
• Status: Terminated
• Phase: Phase 2
• First received: March 24, 2006
• Last updated: April 26, 2012
• Start date: April 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Visilizumab
Visilizumab administered intravenously once per day for two days

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 71875	Hamilton
Canada	Site Reference ID/Investigator# 71873	Winnipeg
Croatia	Site Reference ID/Investigator# 72338	Osijek
Croatia	Site Reference ID/Investigator# 72334	Zagreb
Italy	Site Reference ID/Investigator# 72345	Bologna
Russian Federation	Site Reference ID/Investigator# 72314	Moscow
Russian Federation	Site Reference ID/Investigator# 71953	Nizhny-Novgorod
Russian Federation	Site Reference ID/Investigator# 72315	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 72342	St. Petersburg
Spain	Site Reference ID/Investigator# 72368	Badalona - Barcelona
Spain	Site Reference ID/Investigator# 72366	Majadahonda (Madrid)
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# 71913	Manhasset	New York
United States	Site Reference ID/Investigator# 71894	Savannah	Georgia
United States	Site Reference ID/Investigator# 71897	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Italy,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Day 45	No
Secondary	Comparison of subjects in the three visilizumab dose groups		During the course of the study	No