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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01434576
• Date of registration: 01/09/2011
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences Inc.
• Public title: Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis
• Scientific 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
• Date of first enrolment: December 2011
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01434576
• 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
• Phase: Phase 1

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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-TNFa 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: HGS1025

Drug: Placebo

Primary Outcome(s)

Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy) [Time Frame: 8 weeks]

Clinical Response [Time Frame: 8 weeks]

Secondary Outcome(s)

Type, frequency, and severity of adverse events [Time Frame: Through 8 weeks after the last dose of study agent]

Mucosal healing [Time Frame: 4 weeks & 8 weeks]

Clinical remission [Time Frame: 4 weeks & 8 weeks]

Clinical response [Time Frame: 4 weeks]

Secondary ID(s)

HGS1025-C1106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors