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

Phase 1

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Biological: HGS1025; Drug: Placebo

• Registration Number: NCT01434576
• Lead Sponsor: Human Genome Sciences Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-15
• Study Start: 2011-12
• Primary Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HGS1025 2 mg/kg	HGS1025	-
HGS1025 10 mg/kg	HGS1025	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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