A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.

Official Title

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Conditions

Ulcerative Colitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Clinical response

Secondary Outcome Measures:

• The comparison of subjects in the visilizumab and placebo groups in the following categories: clinical remission
• mucosal healing
• symptomatic response and time to symptomatic response
• symptomatic remission
• durable clinical response
• time to disease progression
• colectomy rates
• time to colectomy
• ability to taper prednisone
• safety
• immunogenicity
• health-related quality of life
• pharmacoeconomic outcomes

Study Start

February 2006; Expected completion: February 2009

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Males and females, 18 years of age or older.
• Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
• Severe active disease, as defined by a Modified Truelove & Witts Severity Index (MTWSI; also known as Lichtiger score) >= 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.
• Negative Clostridium difficile test.
• Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.

Exclusion Criteria:

• UC requiring immediate intervention or toxic megacolon requiring imminent intervention.
• History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
• Presence of Ileostomy.
• White blood cell count less than 2.5 x 10³/mcL; platelet count less than 150 x 10³/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 of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent.
• 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-tumor necrosis factor (TNF)- drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF- 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.
• Unable or willing to discontinue any UC drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 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.

Total Enrolment

150

Contact Details

Fremantle Hospital, Fremantle, 6160, Australia; Recruiting

• Jillian Philpott +61(8) 9431 2698

Flinders Medical Centre, Bedford Park, 5042, Australia; Recruiting

• Peta Leach +61 (0)8 8204 3942

The Royal Melbourne Hospital, Parkville, Australia; Recruiting

• Cathy Pizzey 61-03-9342-7798
• Bernadette Viney 61-03-9342-7798

St. Vincent’s Hospital Melbourne, Fitzroy, Australia; Recruiting

• Danielle Croall 61-3-9288-3597
• Angela Gibbs 61-3-9288-3597

Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia; Recruiting

• Barbara Charlton +61 (2) 9515 8983
• Susan Hoy +61 (2) 9515 8987

Liverpool Hospital, Liverpool, New South Wales, 2170, Australia; Recruiting

• Anne Glass +61 2 9828 3571

Royal Brisbane Hospital-Gastroenterology Dept., Herston, Queensland, 4029, Australia; Recruiting

• Karen Cooley +61 (0)7 3636 4273

The Brisbane IBD Research Centre, South Brisbane, Queensland, Australia; Recruiting

• Sharyn Grossman +61 (0)7 3840 8196
• Kerry Forbes +61 (0)7 3840 8196

Eastern Clinical Research Unit, Box Hill, Victoria, 3128, Australia; Recruiting

• Lai Wan Reid 61 3 9895 0347
• Belinda Headon 61 3 9895 0347

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