Study to Evaluate the Pharmacodynamics and Safety of HGS1... | NCT01434576

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

NCT01434576

Sponsor

Human Genome Sciences Inc.

Status

Withdrawn

Last Update Posted

Aug 2, 2013Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Ulcerative Colitis

Interventions

HGS1025
HGS1025
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor withdrew study for business reasons

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Sep 1, 2011

First Submission Date that Met QC Criteria

Sep 13, 2011

First Posted Date

Sep 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Intervention Names
HGS1025 2 mg/kg	Experimental	Biological: HGS1025
HGS1025 10 mg/kg	Experimental	Biological: HGS1025
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Type, frequency, and severity of adverse events		Through 8 weeks after the last dose of study agent
Clinical response	Decrease in Mayo Score and rectal bleeding.	4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases