Clinical trial NCT01434576: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)
timeFrame: 8 weeks
measure: Clinical Response
timeFrame: 8 weeks
Secondary outcomes:
measure: Type, frequency, and severity of adverse events
timeFrame: Through 8 weeks after the last dose of study agent
measure: Clinical response
timeFrame: 4 weeks
measure: Clinical remission
timeFrame: 4 weeks & 8 weeks
measure: Mucosal healing
timeFrame: 4 weeks & 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: