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

Sponsor
Abbott (Industry)
Overall Status
Terminated
CT.gov ID
NCT00307827
Collaborator
(none)
38
Enrollment
16
Locations
3
Arms
19
Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Visilizumab low dose level

Drug: Visilizumab
Visilizumab administered intravenously once per day for two days
Other Names:
  • Nuvion®; HuM291

    		•
    Experimental: Arm 2

    Visilizumab middle dose level

    Drug: Visilizumab
    Visilizumab administered intravenously once per day for two days
    Other Names:
  • Nuvion®; HuM291

    		•
    Experimental: Arm 3

    Visilizumab high dose level

    Drug: Visilizumab
    Visilizumab administered intravenously once per day for two days
    Other Names:
  • Nuvion®; HuM291

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Secondary Outcome Measures

    1. Comparison of subjects in the three visilizumab dose groups [During the course of the study]

    Eligibility Criteria

    Criteria

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

    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 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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 71894 Savannah Georgia United States 31405
    2 Site Reference ID/Investigator# 71897 Worcester Massachusetts United States 01655
    3 Site Reference ID/Investigator# 71913 Manhasset New York United States 11030
    4 Site Reference ID/Investigator# 71895 Chapel Hill North Carolina United States 27599-7032
    5 Site Reference ID/Investigator# 71896 Cleveland Ohio United States 44106-5066
    6 Site Reference ID/Investigator# 71875 Hamilton Canada L8N 3Z5
    7 Site Reference ID/Investigator# 71873 Winnipeg Canada R3A 1R9
    8 Site Reference ID/Investigator# 72338 Osijek Croatia 31 000
    9 Site Reference ID/Investigator# 72334 Zagreb Croatia 10000
    10 Site Reference ID/Investigator# 72345 Bologna Italy 40138
    11 Site Reference ID/Investigator# 72314 Moscow Russian Federation 111123
    12 Site Reference ID/Investigator# 71953 Nizhny-Novgorod Russian Federation 603126
    13 Site Reference ID/Investigator# 72315 St. Petersburg Russian Federation 196247
    14 Site Reference ID/Investigator# 72342 St. Petersburg Russian Federation
    15 Site Reference ID/Investigator# 72368 Badalona - Barcelona Spain 08916
    16 Site Reference ID/Investigator# 72366 Majadahonda (Madrid) Spain 28222

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Mihail Obrocea, MD, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT00307827
    Other Study ID Numbers:
    • 291-418
    • 2005-003482-17
    First Posted:
    Mar 28, 2006
    Last Update Posted:
    Apr 27, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Abbott
    Steroid-Refractory
    IVSR-UC
    Ulcerative Colitis
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Visilizumab

    Study Results

    No Results Posted as of Apr 27, 2012