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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01434576
• Other study ID #: HGS1025-C1106
• Status: Withdrawn
• Phase: Phase 1
• First received: September 1, 2011
• Last updated: August 1, 2013
• Start date: December 2011

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics of HGS1025 in patients with moderate to severe ulcerative colitis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• HGS1025
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
10 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

Drug:
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)	Change in CCR5 properties; change in inflammatory markers in blood and colon.	8 weeks	No
Primary	Clinical Response	Decrease in Mayo Score and rectal bleeding.	8 weeks	No
Secondary	Type, frequency, and severity of adverse events		Through 8 weeks after the last dose of study agent	Yes
Secondary	Clinical response	Decrease in Mayo Score and rectal bleeding.	4 weeks	No
Secondary	Clinical remission	Decrease in Mayo Score and no rectal bleeding or colon friability.	4 weeks & 8 weeks	No
Secondary	Mucosal healing		4 weeks & 8 weeks	No