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Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HGS1025
HGS1025
Placebo
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults at least 18 years of age
  • Active, moderate to severe ulcerative colitis (UC) confirmed by endoscopy
  • Currently on 1 or more of the following UC treatment medications: 5-aminosalicylates (5-ASA), corticosteroids, azathioprine, 6-mercaptopurine (6MP), and/or other immunosuppressive or immunomodulatory agents including cyclosporine, tacrolimus, methotrexate, and mycophenolic acid
  • Not pregnant or nursing
  • Females of non-childbearing potential or females of childbearing potential must be willing to practice abstinence from intercourse from 2 weeks prior to first dose of study agent and for 8 weeks after the last dose of study agent or use effective contraception for 1 month prior to the 1st dose of study agent and through 8 weeks after the last dose of study agent
  • Males must agree to use effective contraception throughout the study and for 8 weeks after the last dose of study agent
  • Have the ability to provide informed consent and comply with study procedures

Exclusion Criteria:

  • Received any of the following within 60 days of the first dose of study agent: Anti-TNFα therapy; integrin receptor antagonist; intravenous immunoglobulin; high dose prednisone or prednisone equivalent (greater than 60 mg/day); any investigational agent including immunosuppressive/immunomodulatory or non-biologic agents
  • Have had a change in corticosteroid, 5-ASA, or other immunosuppressive/immunomodulatory agents within 30 days of Day 0
  • History of liver disease
  • History of a major organ transplant
  • History of prior large bowel resection
  • Current unstable or uncontrolled acute or chronic diseases not due to UC
  • History of malignant neoplasm within the last 5 years, except for some types of adequately treated cancers of the skin or carcinoma in situ of the uterine cervix
  • Current or recent drug or alcohol abuse or dependence
  • History of a positive test for HIV or test positive for Hepatitis B (HBsAg) or Hepatitis C
  • Have a history of severe drug allergies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    HGS1025 2 mg/kg

    HGS1025 10 mg/kg

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)
    Change in CCR5 properties; change in inflammatory markers in blood and colon.
    Clinical Response
    Decrease in Mayo Score and rectal bleeding.

    Secondary Outcome Measures

    Type, frequency, and severity of adverse events
    Clinical response
    Decrease in Mayo Score and rectal bleeding.
    Clinical remission
    Decrease in Mayo Score and no rectal bleeding or colon friability.
    Mucosal healing

    Full Information

    First Posted
    September 1, 2011
    Last Updated
    August 1, 2013
    Sponsor
    Human Genome Sciences Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01434576
    Brief Title
    Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis
    Official Title
    A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor withdrew study for business reasons
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Human Genome Sciences Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics of HGS1025 in patients with moderate to severe ulcerative colitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HGS1025 2 mg/kg
    Arm Type
    Experimental
    Arm Title
    HGS1025 10 mg/kg
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    HGS1025
    Intervention Description
    2 mg/kg of HGS1025 administered by IV infusion on Day 0, 14, 28 and 56, and then every 28 days thereafter if patient achieves clinical response
    Intervention Type
    Biological
    Intervention Name(s)
    HGS1025
    Intervention Description
    10 mg/kg of HGS1025 administered by IV infusion on Day 0, 14, 28 and 56, and then every 28 days thereafter if patient achieves clinical response
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo administered by IV infusion on Day 0, 14, 28 and 56. Subjects receiving placebo during the first 8 weeks of treatment will be given the option to receive HGS1025 10 mg/kg in the continuation phase of the study.
    Primary Outcome Measure Information:
    Title
    Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)
    Description
    Change in CCR5 properties; change in inflammatory markers in blood and colon.
    Time Frame
    8 weeks
    Title
    Clinical Response
    Description
    Decrease in Mayo Score and rectal bleeding.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Type, frequency, and severity of adverse events
    Time Frame
    Through 8 weeks after the last dose of study agent
    Title
    Clinical response
    Description
    Decrease in Mayo Score and rectal bleeding.
    Time Frame
    4 weeks
    Title
    Clinical remission
    Description
    Decrease in Mayo Score and no rectal bleeding or colon friability.
    Time Frame
    4 weeks & 8 weeks
    Title
    Mucosal healing
    Time Frame
    4 weeks & 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults at least 18 years of age Active, moderate to severe ulcerative colitis (UC) confirmed by endoscopy Currently on 1 or more of the following UC treatment medications: 5-aminosalicylates (5-ASA), corticosteroids, azathioprine, 6-mercaptopurine (6MP), and/or other immunosuppressive or immunomodulatory agents including cyclosporine, tacrolimus, methotrexate, and mycophenolic acid Not pregnant or nursing Females of non-childbearing potential or females of childbearing potential must be willing to practice abstinence from intercourse from 2 weeks prior to first dose of study agent and for 8 weeks after the last dose of study agent or use effective contraception for 1 month prior to the 1st dose of study agent and through 8 weeks after the last dose of study agent Males must agree to use effective contraception throughout the study and for 8 weeks after the last dose of study agent Have the ability to provide informed consent and comply with study procedures Exclusion Criteria: Received any of the following within 60 days of the first dose of study agent: Anti-TNFα therapy; integrin receptor antagonist; intravenous immunoglobulin; high dose prednisone or prednisone equivalent (greater than 60 mg/day); any investigational agent including immunosuppressive/immunomodulatory or non-biologic agents Have had a change in corticosteroid, 5-ASA, or other immunosuppressive/immunomodulatory agents within 30 days of Day 0 History of liver disease History of a major organ transplant History of prior large bowel resection Current unstable or uncontrolled acute or chronic diseases not due to UC History of malignant neoplasm within the last 5 years, except for some types of adequately treated cancers of the skin or carcinoma in situ of the uterine cervix Current or recent drug or alcohol abuse or dependence History of a positive test for HIV or test positive for Hepatitis B (HBsAg) or Hepatitis C Have a history of severe drug allergies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis

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