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

Sponsor
Facet Biotech (Industry)
Overall Status
Terminated
CT.gov ID
NCT00279422
Collaborator
PDL BioPharma, Inc. (Industry)
127
Enrollment
70
Locations
2
Arms
17.9
Duration (Months)
1.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

Drug: visilizumab
Experimental: visilizumab

Drug: visilizumab

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)-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.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles California United States 90048
    2 San Francisco California United States 94115
    3 Gainesville Florida United States 32608
    4 Tampa Florida United States 33606
    5 Atlanta Georgia United States 30342
    6 Macon Georgia United States 31201
    7 Chicago Illinois United States 60637
    8 Indianapolis Indiana United States 46202
    9 Lexington Kentucky United States 40536
    10 Louisville Kentucky United States 40202
    11 Boston Massachusetts United States 02115
    12 Rochester Minnesota United States 55905
    13 New York New York United States 10021
    14 New York New York United States 10029
    15 Pittsburgh Pennsylvania United States
    16 Charleston South Carolina United States 29425
    17 Nashville Tennessee United States
    18 Galveston Texas United States 77555-0764
    19 Camperdown New South Wales Australia 2050
    20 Liverpool New South Wales Australia 2170
    21 Herston Queensland Australia 4029
    22 South Brisbane Queensland Australia
    23 Box Hill Victoria Australia 3128
    24 Bedford Park Australia 5042
    25 Fitzroy Australia
    26 Fremantle Australia 6160
    27 Parkville Australia
    28 Wien Austria
    29 Gent Belgium B-9000
    30 Leuven Belgium 3000
    31 Roeselare Belgium
    32 Calgary Alberta Canada T2N 4N1
    33 London Ontario Canada N685W9
    34 Brno Czech Republic 625 00
    35 Praha Czech Republic
    36 Amiens Cedex France 80054
    37 Clichy France 92110
    38 Lille France 59037
    39 Marseille France
    40 Nantes France
    41 NICE Cedex France
    42 Paris France
    43 Berlin Germany 13353
    44 Frankfurt Germany D-60431
    45 Freiburg Germany
    46 Hannover Germany 30625
    47 Kiel Germany 24105
    48 Munchen Germany
    49 Rostock Germany 18055
    50 Stuttgart Germany 70376
    51 Argenti Döme Hungary 2601
    52 Budapest Hungary H-1083
    53 Budapest Hungary H-1088
    54 Csabai Kapu Hungary 3501
    55 Debrecen Hungary H-4012
    56 Győr, Vasvári Pál Hungary 9024
    57 Szekszárd Hungary H-7100
    58 Veszprém Hungary H-8220
    59 Haifa Israel
    60 Tel Aviv Israel 64329
    61 Tel Hashomer Israel 52621
    62 Amsterdam Netherlands 1105
    63 Rotterdam Netherlands
    64 Oslo Norway N-0027
    65 Prinsens Norway
    66 Tromsø Norway 9038
    67 Mickieviczova Slovakia 81369
    68 Kharkiv Ukraine 61001
    69 Kyiv Ukraine 01021
    70 Odessa Ukraine 65025

    Sponsors and Collaborators

    • Facet Biotech
    • PDL BioPharma, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Facet Biotech
    ClinicalTrials.gov Identifier:
    NCT00279422
    Other Study ID Numbers:
    • 291-415
    First Posted:
    Jan 19, 2006
    Last Update Posted:
    Mar 12, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Facet Biotech
    Intravenous, Steroid-Refractory, Ulcerative Colitis
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Visilizumab

    Study Results

    No Results Posted as of Mar 12, 2012