Ulcerative Colitis
Conditions
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.
Interventions
BIOLOGICALHGS1025
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
DRUGPlacebo
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.
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy) | 8 weeks | Change in CCR5 properties; change in inflammatory markers in blood and colon. |
| Clinical Response | 8 weeks | Decrease in Mayo Score and rectal bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type, frequency, and severity of adverse events | Through 8 weeks after the last dose of study agent | — |
| Clinical response | 4 weeks | Decrease in Mayo Score and rectal bleeding. |
| Clinical remission | 4 weeks & 8 weeks | Decrease in Mayo Score and no rectal bleeding or colon friability. |
| Mucosal healing | 4 weeks & 8 weeks | — |
Outcome results
None listed