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

NCT00279422 | Terminated Phase 2 DMC

• 1 other identifier: 291-415
• Study Type: interventional
• Target: 127
• Locations: 13 countries
• Sites: 61

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Intravenous, Steroid-Refractory, Ulcerative Colitis

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: visilizumab

visilizumab

EXPERIMENTAL

Drug: visilizumab

Interventions

visilizumab DRUG

visilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α drug within 2 weeks of randomization.
• Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
• 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.

Sponsors & Collaborators

• Facet Biotech: lead
• PDL BioPharma, Inc.: collaborator

Study Sites (70)

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Los Angeles, California, 90048, United States

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San Francisco, California, 94115, United States

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Gainesville, Florida, 32608, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30342, United States

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Macon, Georgia, 31201, United States

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Chicago, Illinois, 60637, United States

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Indianapolis, Indiana, 46202, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Boston, Massachusetts, 02115, United States

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Rochester, Minnesota, 55905, United States

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New York, New York, 10021, United States

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New York, New York, 10029, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, United States

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Galveston, Texas, 77555-0764, United States

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Camperdown, New South Wales, 2050, Australia

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Liverpool, New South Wales, 2170, Australia

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Herston, Queensland, 4029, Australia

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South Brisbane, Queensland, Australia

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Box Hill, Victoria, 3128, Australia

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Bedford Park, 5042, Australia

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Fitzroy, Australia

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Fremantle, 6160, Australia

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Parkville, Australia

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Vienna, Austria

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Ghent, B-9000, Belgium

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Leuven, 3000, Belgium

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Roeselare, Belgium

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Calgary, Alberta, T2N 4N1, Canada

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London, Ontario, N685W9, Canada

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Brno, 625 00, Czechia

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Prague, Czechia

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Amiens, Cedex, 80054, France

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Clichy, 92110, France

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Lille, 59037, France

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Marseille, France

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Nantes, France

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Nice, France

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Paris, France

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Berlin, 13353, Germany

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Frankfurt, D-60431, Germany

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Freiburg im Breisgau, Germany

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Hanover, 30625, Germany

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Kiel, 24105, Germany

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München, Germany

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Rostock, 18055, Germany

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Stuttgart, 70376, Germany

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Argenti Döme, 2601, Hungary

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Budapest, H-1083, Hungary

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Budapest, H-1088, Hungary

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Csabai Kapu, 3501, Hungary

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Debrecen, H-4012, Hungary

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Győr, Vasvári Pál, 9024, Hungary

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Szekszárd, H-7100, Hungary

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Veszprém, H-8220, Hungary

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Haifa, Israel

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Tel Aviv, 64329, Israel

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Tel Litwinsky, 52621, Israel

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Amsterdam, 1105, Netherlands

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Rotterdam, Netherlands

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Oslo, N-0027, Norway

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Prinsens, Norway

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Tromsø, 9038, Norway

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Mickieviczova, 81369, Slovakia

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Kharkiv, 61001, Ukraine

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Kyiv, 01021, Ukraine

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Odesa, 65025, Ukraine

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Related Publications (1)

• Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.

  PMID: 20947884 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

visilizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

IL (3); CZ (2); BE (3); FR (7); HU (8); CA (2); NL (2); NO (3); US (18); SL (1); UA (3); AU (1); DE (8)