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

This study has been withdrawn prior to enrollment.
(Sponsor withdrew study for business reasons)
Sponsor:
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT01434576
First received: September 1, 2011
Last updated: August 1, 2013
Last verified: August 2013

September 1, 2011
August 1, 2013
December 2011
December 2012   (final data collection date for primary outcome measure)
  • Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in CCR5 properties; change in inflammatory markers in blood and colon.
  • Clinical Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Decrease in Mayo Score and rectal bleeding.
Same as current
Complete list of historical versions of study NCT01434576 on ClinicalTrials.gov Archive Site
  • Type, frequency, and severity of adverse events [ Time Frame: Through 8 weeks after the last dose of study agent ] [ Designated as safety issue: Yes ]
  • Clinical response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Decrease in Mayo Score and rectal bleeding.
  • Clinical remission [ Time Frame: 4 weeks & 8 weeks ] [ Designated as safety issue: No ]
    Decrease in Mayo Score and no rectal bleeding or colon friability.
  • Mucosal healing [ Time Frame: 4 weeks & 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • Biological: HGS1025
    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
  • Biological: HGS1025
    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
  • Drug: Placebo
    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.
  • Experimental: HGS1025 2 mg/kg
    Intervention: Biological: HGS1025
  • Experimental: HGS1025 10 mg/kg
    Intervention: Biological: HGS1025
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01434576
HGS1025-C1106
No
Human Genome Sciences Inc.
Human Genome Sciences Inc.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
Human Genome Sciences Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP