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A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease (SHIELD-1)

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK1605786A

Placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, capsule, GSK1605786A, quality of life, inflammatory bowel disease, oral therapy

Eligibility Criteria

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

Inclusion Criteria:

Male or female subjects aged 18 years or older
Written informed consent
Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement
Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry
History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants
Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline
Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers [elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin] at Screening
Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease
Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system
Females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with a failure rate of less than 1% for the duration of this study

Exclusion Criteria:

If female: pregnant, has a positive pregnancy test or is breast-feeding
Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease
Diagnosis of ulcerative or indeterminate colitis
Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period
Extensive colonic resection, subtotal or total colectomy
Presence of ileostomies, colostomies or rectal pouches
Known fixed symptomatic stenoses
History of more than 3 small bowel resections or diagnosis of short bowel syndrome
Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames
1. Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening
2. Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening
3. Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening
4. Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to screening
5. Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening
6. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening
7. Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening
Positive immunoassay for Clostridium difficile
Known human immunodeficiency virus (HIV) infection
Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
Immunisation with a live vaccine within 4 weeks of screening, with the exception of influenza vaccine
Active or latent tuberculosis infection
Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH)
Positive test for Hepatitis B or Hepatitis C antibody at screening
Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study
History or evidence of adenomatous colonic polyps that have not been removed
History of evidence of colonic mucosal dysplasia
Current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected)
Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
Medical history of sensitivity to any of the components of GSK1605786A
Use of any investigational product within 30 days prior to screening

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

GSK1605786A 500mg once daily

GSK1605786A 500mg twice daily

Arm Description

orally administered

Outcomes

Primary Outcome Measures

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12

CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.

Secondary Outcome Measures

Percentage of Participants With CDAI Remission at Week 12

CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. Participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission at Week 12 was presented.

Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12

Responders were defined as participants with CDAI decrease from baseline of >= 100 points. CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI decrease from baseline of >=100 points was presented.

Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12

Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission defined as a CDAI score of less than 150 points at other time points was presented.

Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8

CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of Participants with a clinical response CDAI decrease from baseline of >=100 points at Week 8 was presented.

Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8

Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI <150 points at Week 8 was presented.

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12

The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. Each item response was graded from 1 to 7 for each area evaluated. A higher score indicated better function in that area. Total IBDQ score was obtained by summing up scores for all 32 questions. Total IBDQ score ranged from 32 to 224. A higher score indicated better quality of life and lower score indicated worse quality of life. Day 1 assessment was considered as Baseline. Change from Baseline was calculated by subtracting value at Baseline from value at Weeks 8 and 12.

Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Full Information

NCT ID

NCT01277666

First Posted

January 13, 2011

Last Updated

August 21, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01277666

Brief Title

A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

Acronym

SHIELD-1

Official Title

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 20, 2010 (Actual)

Primary Completion Date

July 11, 2013 (Actual)

Study Completion Date

July 11, 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

This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

Detailed Description

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of two oral doses of GSK1605786A (500 mg once daily, 500 mg twice daily) as compared to placebo in the induction of clinical response over a 12-week treatment period in subjects with moderately-to-severely active Crohn's disease. Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of remission. The study is planned to randomise approximately 600 subjects (200 subjects/group) with active Crohn's disease, diagnosed for at least 4 months with a documented history of disease in the small and/or large intestine, and characterised by a Crohn's Disease Activity Index (CDAI) score between 220 to and 450, inclusive. Subjects must have reported an inadequate response or intolerance to Crohn's disease treatment with corticosteroids or immunosuppressants. Inclusion of subjects who received prior treatment with a biologic anti-tumour necrosis factor (TNF) agent will be limited to approximately 50% of the study population. All subjects are required to have a diagnosis with identification of anatomic location of Crohn's disease, which has been established by visualisation of the gastrointestinal tract within 12 months of screening. Subjects who have not had a visualisation of the gastrointestinal tract within 12 months are required to undergo an endoscopic assessment during the screening period. Subjects will be required to have evidence of current active inflammation at the time of randomisation either by endoscopy or by inflammatory biomarkers [elevated C-reactive protein (CRP) greater than the upper limit of normal (ULN) plus a positive faecal calprotectin test]. Subjects who do not meet the requirements based on inflammatory biomarker test results will be required to qualify based on endoscopic assessment during screening. Subjects will be allowed to participate in the study while continuing on stable doses of agents typically used to treat Crohn's disease. Following the screening period, subjects will be randomised at baseline to receive blinded treatment with one of two doses of GSK1605786A (500 mg once daily or twice daily) or placebo for 12 weeks. Response and remission endpoints, using the CDAI, will be evaluated at Weeks 4, 8 and 12.

6. Conditions and Keywords

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

Crohn's Disease

Keywords

Crohn's disease, capsule, GSK1605786A, quality of life, inflammatory bowel disease, oral therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

608 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

orally administered

Arm Title

GSK1605786A 500mg once daily

Arm Type

Experimental

Arm Description

orally administered

Arm Title

GSK1605786A 500mg twice daily

Arm Type

Experimental

Arm Description

orally administered

Intervention Type

Drug

Intervention Name(s)

GSK1605786A

Intervention Description

500 mg twice daily, administered orally for 12 weeks

Intervention Type

Drug

Intervention Name(s)

GSK1605786A

Intervention Description

500 mg once daily, administered orally for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules, administered orally for 12 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With CDAI Remission at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12

Description

Time Frame

At Week 8 and 12

Title

Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12

Description

Time Frame

Week 8 and 12

Title

Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8

Description

Time Frame

Week 8

Title

Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8

Description

Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI <150 points at Week 8 was presented.

Time Frame

Week 8

Title

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12

Description

Time Frame

Baseline (Week 0), Week 8 and Week 12

Title

Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

Description

Time Frame

Up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged 18 years or older Written informed consent Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers [elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin] at Screening Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system Females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with a failure rate of less than 1% for the duration of this study Exclusion Criteria: If female: pregnant, has a positive pregnancy test or is breast-feeding Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease Diagnosis of ulcerative or indeterminate colitis Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period Extensive colonic resection, subtotal or total colectomy Presence of ileostomies, colostomies or rectal pouches Known fixed symptomatic stenoses History of more than 3 small bowel resections or diagnosis of short bowel syndrome Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to screening Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening Positive immunoassay for Clostridium difficile Known human immunodeficiency virus (HIV) infection Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening Immunisation with a live vaccine within 4 weeks of screening, with the exception of influenza vaccine Active or latent tuberculosis infection Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH) Positive test for Hepatitis B or Hepatitis C antibody at screening Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study History or evidence of adenomatous colonic polyps that have not been removed History of evidence of colonic mucosal dysplasia Current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected) Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B) Medical history of sensitivity to any of the components of GSK1605786A Use of any investigational product within 30 days prior to screening

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

Los Angeles

State/Province

California

ZIP/Postal Code

90015

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

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

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

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

Maitland

State/Province

Florida

ZIP/Postal Code

32751

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

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

GSK Investigational Site

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

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

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

48109-5048

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

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

GSK Investigational Site

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

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

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

GSK Investigational Site

City

Egg Harbor City

State/Province

New Jersey

ZIP/Postal Code

08234

Country

United States

Facility Name

GSK Investigational Site

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

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

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

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

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

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77034-0550

Country

United States

Facility Name

GSK Investigational Site

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77505

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

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

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

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

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

Edegem

ZIP/Postal Code

2650

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

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

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3M9

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 4A6

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

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

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 3P8

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

GSK Investigational Site

City

Levis

State/Province

Quebec

ZIP/Postal Code

G6V 3Z1

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

Brno

ZIP/Postal Code

625 00

Country

Czechia

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

2650

Country

Denmark

Facility Name

GSK Investigational Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

GSK Investigational Site

City

Amiens cedex 1

ZIP/Postal Code

80054

Country

France

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

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

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

Braunschweig

State/Province

Niedersachsen

ZIP/Postal Code

38126

Country

Germany

Facility Name

GSK Investigational Site

City

Brinkum/Stuhr

State/Province

Niedersachsen

ZIP/Postal Code

28816

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

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

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48159

Country

Germany

Facility Name

GSK Investigational Site

City

Ludwigshafen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67067

Country

Germany

Facility Name

GSK Investigational Site

City

Dessau

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06847

Country

Germany

Facility Name

GSK Investigational Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06120

Country

Germany

Facility Name

GSK Investigational Site

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07747

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

12157

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

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

GSK Investigational Site

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

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

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

GSK Investigational Site

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90127

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

ZIP/Postal Code

16132

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

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

460-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

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

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

113-8519

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

Daegu

ZIP/Postal Code

705-717

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Pusan

ZIP/Postal Code

602-739

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

130-702

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-230

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

Almere

ZIP/Postal Code

1315 RA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

EDE

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

GSK Investigational Site

City

Heerlen

ZIP/Postal Code

6419 PC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Auckland

ZIP/Postal Code

1148

Country

New Zealand

Facility Name

GSK Investigational Site

City

Dunedin

ZIP/Postal Code

9054

Country

New Zealand

Facility Name

GSK Investigational Site

City

Hamilton

ZIP/Postal Code

3204

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

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

GSK Investigational Site

City

Tauranga.

ZIP/Postal Code

3143

Country

New Zealand

Facility Name

GSK Investigational Site

City

Bodø

ZIP/Postal Code

8005

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

N-0456

Country

Norway

Facility Name

GSK Investigational Site

City

Tromsø

ZIP/Postal Code

9038

Country

Norway

Facility Name

GSK Investigational Site

City

Trondheim

ZIP/Postal Code

7030

Country

Norway

Facility Name

GSK Investigational Site

City

Tønsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

GSK Investigational Site

City

Ålesund

ZIP/Postal Code

6017

Country

Norway

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

Elblag

ZIP/Postal Code

82-300

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

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

Galdakao/Vizcaya

ZIP/Postal Code

48960

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-416 85

Country

Sweden

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

Umeå

ZIP/Postal Code

SE-901 85

Country

Sweden

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

Nottingham

ZIP/Postal Code

NG7 2UH

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

A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

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A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease (SHIELD-1)

Crohn's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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