An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

— SHIELD-4  

Official title:

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01536418
• Other study ID #: 114643
• Status: Terminated
• Phase: Phase 3
• First received: February 16, 2012
• Last updated: January 25, 2018
• Start date: November 11, 2011
• Est. completion date: October 17, 2013

Study information

• Verified date: January 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

Description:

This is a multi-centre, double-blind, randomised, active treatment, parallel group study designed to induce clinical response and/or clinical remission with two oral doses of GSK1605786A (500 milligrams once daily, 500 milligrams twice daily) over a 12-week treatment period in subjects with moderately-to-severely active Crohn's disease. The primary objective of this study is to qualify subjects for enrolment into a follow up 52 week maintenance study CCX114157. Subjects who achieve induction of clinical response (CDAI decrease from baseline of at least 100 points) or remission (CDAI score less than 150) at Week 12 following treatment with GSK1605786A will be eligible for enrolment into the maintenance study CCX114157. Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission.

The study is planned to randomise approximately 900 subjects (450 subjects per group) with active Crohn's disease who have been diagnosed for at least 4 months, with documented history of disease in the small and/or large intestine, and characterised by a CDAI score between 220 to 450 (inclusive). Subjects will be required to have evidence of current active inflammation by elevated C-reactive protein (greater than the upper limit of normal of the highly sensitive C-reactive protein test) OR an elevated level of faecal calprotectin. Subjects will be allowed to participate in the study while continuing on stable doses of agents typically used to treat Crohn's disease. Inclusion of subjects who received prior treatment with an anti-tumor necrosis factor agent and discontinued due to loss or lack of efficacy will be limited to approximately 50 percent of the study population. Following a 3-week screening period, subjects will be randomised at baseline to receive blinded treatment with one of two doses of GSK1605786A (500 milligrams once daily or twice daily) for 12 weeks. All subjects meeting the definition of responder (CDAI decrease from baseline of at least 100 points) or who are in remission (CDAI score less than 150 points) at Week 12 will be eligible for randomisation into an ongoing maintenance study (CCX114157). Subjects who do not meet the definition of responder or who are not in remission at Week 12 will not be eligible to participate in study CCX114157.

For subjects who complete the study the minimum duration of participation is 15 weeks and the maximum duration is 19 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 255
• Est. completion date: October 17, 2013
• Est. primary completion date: October 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects aged 18 years or older

• Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications

• Diagnosis of Crohn's disease for more than 4 months with small bowel and/or colonic involvement

• Current evidence of moderately-to-severely active disease defined by a baseline Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive

• Confirmation of active disease by elevated CRP (greater than or equal to the upper limit of normal for the highly sensitive C-reactive protein test) or elevated levels of faecal calprotectin

• History of inadequate response and/or intolerance or adverse event leading to discontinuation of at least one of the following treatments for Crohn's disease: corticosteroids or immunosuppressants

• 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

• Female subjects of child-bearing potential are eligible if not pregnant or nursing and committed to use of contraceptive methods with a failure rate of less than 1 percent per year

Exclusion Criteria:

• Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac disease (elevated anti-tissue transglutaminase antibodies)

• Diagnosis of ulcerative or indeterminate colitis

• Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period

• Bowel surgery, other than appendectomy, within 12 weeks prior to screening and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period

• Extensive colonic resection, subtotal or total colectomy

• Presence of ileostomies, colostomies or rectal pouches

• Fixed symptomatic stenoses of small bowel or colon

• 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 medicaitons

• Use of prohibited medications, including enteral feeding or elemental diet, within their specified timeframes and throughout the study. Prohibited medications include the following:

1. Biologic use: Use of any TNF inhibitor (such as infliximab, adalimumab or certolizumab) or natalizumab within 10 weeks prior to Randomisation

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. Enteral feeding: Use of tube or enteral feeding, elemental diet within 2 weeks prior to Screening

6. Rectal Treatment: Use of 5-aminosalicylates or corticosteroid enemas or suppositories within 2 weeks prior to Screening

7. Leukocytapheresis or granulocytapheresis within 2 weeks prior to Screening

8. Paracetamol or acetaminophen greater than 2 grams per day

9. Opioid analgesics for worsening Crohn's disease pain are prohibited when used on a regular daily basis for more than 3 days

10. Digoxin or related cardiac glycosides: Use within 7 days prior to Screening

11. Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)

• Positive immunoassay for Clostridium difficile

• Known HIV infection

• Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening

• Immunization with a live vaccine within 4 weeks of Screening and throughout the study with the exception of the influenza vaccine

• Positive hepatitis B surface antigen or hepatitis B core antibody test or positive Hepatitis C test result at Screening

• Active or latent tuberculosis infection determined by results of QuantiFERON TB Gold test

• Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks

• Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise

• Evidence of hepatic dysfunction, viral hepatitis, or abnormalities in liver function test results

• Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds

• Congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection

• 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)

• History of evidence of adenomatous colonic polyps that have not been removed.

• History of evidence of colonic mucosal dysplasia

• If female, is pregnant, has a positive pregnancy test or is breast-feeding

• Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (such as an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematologic, or neurological condition or mental impairment)

• Medical history of sensitivity to any of the components of GSK1605786A (microcrystalline cellulose, crospovidone, sodium stearyl fumarate).

• Use of any investigational product within 30 days prior to screening

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• GSK1605786A
500 milligrams once daily, orally administered for 12 weeks
• GSK1605786A
500 milligrams twice daily, orally adminstered for 12 weeks

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Bankstown	New South Wales
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Fitzroy	Victoria
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Prahran	Victoria
Austria	GSK Investigational Site	Hall in Tirol
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Oberpullendorf
Austria	GSK Investigational Site	St.Veit/Glan
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Kortrijk
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Roeselare
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	London	Ontario
Chile	GSK Investigational Site	Vina del Mar
Czechia	GSK Investigational Site	Hradec Králové
Czechia	GSK Investigational Site	Olomouc
Czechia	GSK Investigational Site	Praha 4
Czechia	GSK Investigational Site	Praha 9
Czechia	GSK Investigational Site	Teplice
Czechia	GSK Investigational Site	Usti nad Orlici
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Koebenhavn NV
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Clichy cedex
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Paris cedex 10
France	GSK Investigational Site	Saint-Priest en Jarez
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Brinkum/Stuhr	Niedersachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weiden	Bayern
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Heraklion, Crete
Greece	GSK Investigational Site	Ioannina
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Bekescsaba
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Mosonmagyaróvár
Hungary	GSK Investigational Site	Szekszárd
Hungary	GSK Investigational Site	Vác
Israel	GSK Investigational Site	Afula
Israel	GSK Investigational Site	Beer Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Holon
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Petah Tikva
Israel	GSK Investigational Site	Ramat-Gan
Israel	GSK Investigational Site	Tel Aviv
Israel	GSK Investigational Site	Zerifin
Italy	GSK Investigational Site	Genova
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Wakayama
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Pusan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Wonju
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	EDE
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Rotterdam
New Zealand	GSK Investigational Site	Canterbury
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Lower Hutt
New Zealand	GSK Investigational Site	Otahuhu
New Zealand	GSK Investigational Site	Takapuna, Auckland
New Zealand	GSK Investigational Site	Tauranga.
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Sopot
Poland	GSK Investigational Site	Wroclaw
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Porto
Portugal	GSK Investigational Site	Viseu
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Lipetsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Rostov-on-Don
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St.Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Nove Mesto nad Vahom
Slovakia	GSK Investigational Site	Presov
Slovakia	GSK Investigational Site	Trnava
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Fuenlabrada (Madrid)
Spain	GSK Investigational Site	Galdakao/Vizcaya
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Marbella
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	Santander
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Zürich
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
Turkey	GSK Investigational Site	Ankara
Ukraine	GSK Investigational Site	Chernivtsi
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Vinnytsya
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne
United Kingdom	GSK Investigational Site	Oxford
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesterfield	Michigan
United States	GSK Investigational Site	Chevy Chase	Maryland
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Christiansburg	Virginia
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lake Success	New York
United States	GSK Investigational Site	Lee's Summit	Missouri
United States	GSK Investigational Site	Little Rock	Arizona
United States	GSK Investigational Site	Littleton	Colorado
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Mexico	Missouri
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Port Orange	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Suwanee	Georgia
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Clinical Response at Week 12	Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.	At Week 12
Secondary	Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12	Clinical remission is defined as a CDAI score of <150 points. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If the Baseline value was <150, the participant was not considered to have achieved remission.	Week 8 and Week 12
Secondary	Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12	Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.	Both Week 8 and Week 12
Secondary	Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12	Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.	Baseline (Screening) and Weeks 4, 8, and Week 12
Secondary	Change From Baseline in Faecal Calprotectin at Week 12	Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.	Baseline (Screening) and Week 12
Secondary	Pharmacokinetics (PK) of GSK1605786A	The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.	Baseline (Screening) and Week 12
Secondary	Pharmacogenetic Analyses	Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.	Post randomization any time during early two weeks