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Open-Label Extension Study of GSK1605786A (SHIELD-3)

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK1605786A

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previous participation in a GSK-sponsored study with GSK1605786A
Written informed consent prior to any study-specific procedures
Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate

Exclusion Criteria:

If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
Fixed symptomatic stenoses or strictures of small bowel or colon
Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
Evidence of hepatic dysfunction or viral hepatitis
Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GSK1605786A

Arm Description

500 milligrams twice daily

Outcomes

Primary Outcome Measures

Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product.

Secondary Outcome Measures

Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period

The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Change From Baseline (Week 0) in Heart Rate (HR) Over Period

The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters

Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.

Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters

Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.

Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)

Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.

Change From Baseline (Week 0) in Total Bilirubin

Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.

Change From Baseline (Week 0) in Albumin

Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.

Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value

QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.

Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks

The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks

The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.

Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks

The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.

Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks

IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.

Full Information

NCT ID

NCT01318993

First Posted

March 3, 2011

Last Updated

August 16, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01318993

Brief Title

Open-Label Extension Study of GSK1605786A

Acronym

SHIELD-3

Official Title

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.

Study Start Date

April 1, 2011 (undefined)

Primary Completion Date

September 1, 2013 (Actual)

Study Completion Date

October 29, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

Detailed Description

This is a multi-centre, open-label extension study to assess the long-term safety, tolerability and effectiveness of GSK1605786A in subjects with Crohn's disease. Subjects will enter the study via one of three routes: completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI decrease of at least 100 points) or clinical remission (CDAI score less than 150) at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor completion of maintenance study CCX114157 at Week 52 withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability. It is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily. The study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended. Study assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

399 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1605786A

Arm Type

Experimental

Arm Description

500 milligrams twice daily

Intervention Type

Drug

Intervention Name(s)

GSK1605786A

Intervention Description

500 milligrams twice daily

Primary Outcome Measure Information:

Title

Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)

Description

Time Frame

Up to Week 112

Secondary Outcome Measure Information:

Title

Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period

Description

Time Frame

Baseline (Week 0) and up to Week 112

Title

Change From Baseline (Week 0) in Heart Rate (HR) Over Period

Description

Time Frame

Baseline (week 0) and up to Week 112

Title

Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters

Description

Time Frame

Baseline (Week 0) and up to Week 112

Title

Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters

Description

Time Frame

Baseline (Week 0) and up to Week 112

Title

Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)

Description

Time Frame

Baseline (Week 0) and up to Week 112

Title

Change From Baseline (Week 0) in Total Bilirubin

Description

Time Frame

Baseline (Week 0) and up to Week 112

Title

Change From Baseline (Week 0) in Albumin

Description

Time Frame

Baseline (Week 0) and up to Week 112

Title

Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value

Description

Time Frame

Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)

Title

Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks

Description

Time Frame

Baseline (Week 0) and up to 108 weeks

Title

Description

Time Frame

Baseline (Week 0) and up to 108 weeks

Title

Description

The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.

Time Frame

Baseline (Week 0) and up to 112 weeks

Title

Description

Time Frame

Baseline (Week 0) and up to 112 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previous participation in a GSK-sponsored study with GSK1605786A Written informed consent prior to any study-specific procedures Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate Exclusion Criteria: If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result Fixed symptomatic stenoses or strictures of small bowel or colon Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks Evidence of hepatic dysfunction or viral hepatitis Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arizona

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

GSK Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

GSK Investigational Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80215

Country

United States

Facility Name

GSK Investigational Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

GSK Investigational Site

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

GSK Investigational Site

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256-6004

Country

United States

Facility Name

GSK Investigational Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342-5006

Country

United States

Facility Name

GSK Investigational Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0298

Country

United States

Facility Name

GSK Investigational Site

City

Hammond

State/Province

Louisiana

ZIP/Postal Code

70403

Country

United States

Facility Name

GSK Investigational Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

GSK Investigational Site

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

GSK Investigational Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

GSK Investigational Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21286

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

GSK Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5682

Country

United States

Facility Name

GSK Investigational Site

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

GSK Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

GSK Investigational Site

City

Lee's Summit

State/Province

Missouri

ZIP/Postal Code

64064

Country

United States

Facility Name

GSK Investigational Site

City

Mexico

State/Province

Missouri

ZIP/Postal Code

65265-3726

Country

United States

Facility Name

GSK Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11206

Country

United States

Facility Name

GSK Investigational Site

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733-9292

Country

United States

Facility Name

GSK Investigational Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

GSK Investigational Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7080

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

GSK Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

GSK Investigational Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-1610

Country

United States

Facility Name

GSK Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

GSK Investigational Site

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

GSK Investigational Site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

GSK Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

GSK Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

GSK Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

GSK Investigational Site

City

Bankstown

State/Province

New South Wales

ZIP/Postal Code

2200

Country

Australia

Facility Name

GSK Investigational Site

City

Hersten

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

GSK Investigational Site

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

GSK Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

GSK Investigational Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

GSK Investigational Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

GSK Investigational Site

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

GSK Investigational Site

City

Hall in Tirol

ZIP/Postal Code

6060

Country

Austria

Facility Name

GSK Investigational Site

City

Linz

ZIP/Postal Code

A-4021

Country

Austria

Facility Name

GSK Investigational Site

City

Oberpullendorf

ZIP/Postal Code

7350

Country

Austria

Facility Name

GSK Investigational Site

City

St.Veit/Glan

ZIP/Postal Code

9300

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1050

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

GSK Investigational Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

Country

Canada

Facility Name

GSK Investigational Site

City

Abbotsford

State/Province

British Columbia

ZIP/Postal Code

V2S 3N5

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2K5

Country

Canada

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

GSK Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

GSK Investigational Site

City

Vina del Mar

ZIP/Postal Code

2520012

Country

Chile

Facility Name

GSK Investigational Site

City

Hradec Králové

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

77520

Country

Czechia

Facility Name

GSK Investigational Site

City

Ostrava - Vitkovice

ZIP/Postal Code

70384

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 7

ZIP/Postal Code

17004

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 9

ZIP/Postal Code

190 61

Country

Czechia

Facility Name

GSK Investigational Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

GSK Investigational Site

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

GSK Investigational Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

GSK Investigational Site

City

Hvidovre

ZIP/Postal Code

2605

Country

Denmark

Facility Name

GSK Investigational Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

EE-10138

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Clichy cedex

ZIP/Postal Code

92118

Country

France

Facility Name

GSK Investigational Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Nantes cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Nice cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

GSK Investigational Site

City

Pessac cedex

ZIP/Postal Code

33604

Country

France

Facility Name

GSK Investigational Site

City

Saint-Priest en Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

GSK Investigational Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

GSK Investigational Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Minden

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

32423

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20148

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22559

Country

Germany

Facility Name

GSK Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1136

Country

Hungary

Facility Name

GSK Investigational Site

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

GSK Investigational Site

City

Mosonmagyaróvár

ZIP/Postal Code

9200

Country

Hungary

Facility Name

GSK Investigational Site

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Facility Name

GSK Investigational Site

City

Vác

ZIP/Postal Code

2600

Country

Hungary

Facility Name

GSK Investigational Site

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

GSK Investigational Site

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

GSK Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

GSK Investigational Site

City

Ramat-Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

GSK Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90127

Country

Italy

Facility Name

GSK Investigational Site

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

460-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

818-8502

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

720-8520

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

892-0846

Country

Japan

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

892-8512

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

981-3213

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

530-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

GSK Investigational Site

City

Busan

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

705-717

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

130702

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Wonju

ZIP/Postal Code

220701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Dunedin

ZIP/Postal Code

9054

Country

New Zealand

Facility Name

GSK Investigational Site

City

Lower Hutt

ZIP/Postal Code

6007

Country

New Zealand

Facility Name

GSK Investigational Site

City

Otahuhu, Auckland

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

GSK Investigational Site

City

Tauranga.

ZIP/Postal Code

3143

Country

New Zealand

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-681

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-607

Country

Poland

Facility Name

GSK Investigational Site

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

GSK Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

53-333

Country

Poland

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1769-001

Country

Portugal

Facility Name

GSK Investigational Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

GSK Investigational Site

City

Viseu

ZIP/Postal Code

3504-509

Country

Portugal

Facility Name

GSK Investigational Site

City

Kazan

ZIP/Postal Code

420064

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Lipetsk

ZIP/Postal Code

398055

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Rostov-on-Don

ZIP/Postal Code

344091

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Samara

ZIP/Postal Code

443011

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197047

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

831 04

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

GSK Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Nove Mesto nad Vahom

ZIP/Postal Code

915 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Trnava

ZIP/Postal Code

917 02

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

GSK Investigational Site

City

Claremont

ZIP/Postal Code

7708

Country

South Africa

Facility Name

GSK Investigational Site

City

Observatory

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Parktown

ZIP/Postal Code

2192

Country

South Africa

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Elche

ZIP/Postal Code

03293

Country

Spain

Facility Name

GSK Investigational Site

City

Fuenlabrada (Madrid)

ZIP/Postal Code

28942

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Marbella

ZIP/Postal Code

29600

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

GSK Investigational Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-182 88

Country

Sweden

Facility Name

GSK Investigational Site

City

Bern

ZIP/Postal Code

3004

Country

Switzerland

Facility Name

GSK Investigational Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

GSK Investigational Site

City

Chernivtsi

ZIP/Postal Code

58005

Country

Ukraine

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49044

Country

Ukraine

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83017

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

Country

Ukraine

Facility Name

GSK Investigational Site

City

Odesa

ZIP/Postal Code

65117

Country

Ukraine

Facility Name

GSK Investigational Site

City

Simferopol

ZIP/Postal Code

95017

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsya

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

GSK Investigational Site

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Open-Label Extension Study of GSK1605786A

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Open-Label Extension Study of GSK1605786A (SHIELD-3)

Crohn's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial