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

NCT01434576 | Withdrawn Phase 1

• 1 other identifier: HGS1025-C1106
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)

  Change in CCR5 properties; change in inflammatory markers in blood and colon.

  8 weeks

• Clinical Response

  Decrease in Mayo Score and rectal bleeding.

  8 weeks

Secondary Outcomes (4)

• Type, frequency, and severity of adverse events

  Through 8 weeks after the last dose of study agent

• Clinical response

  4 weeks

• Clinical remission

  4 weeks & 8 weeks

• Mucosal healing

  4 weeks & 8 weeks

Study Arms (3)

HGS1025 2 mg/kg

EXPERIMENTAL

Biological: HGS1025

HGS1025 10 mg/kg

EXPERIMENTAL

Biological: HGS1025

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HGS1025 BIOLOGICAL

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

HGS1025 2 mg/kg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Human Genome Sciences Inc.: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 15, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Last Updated: August 2, 2013

Record last verified: 2013-08