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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Biological: HGS1025
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HGS1025 2 mg/kg 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
Experimental: HGS1025 10 mg/kg 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
Placebo Comparator: Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434576

Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT01434576     History of Changes
Other Study ID Numbers: HGS1025-C1106
Study First Received: September 1, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014