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)

August 21, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Crohn's Disease

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

608

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Bankstown, New South Wales, Australia, 2200
    - GSK Investigational Site
- Queensland
  - Hersten, Queensland, Australia, 4029
    - GSK Investigational Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - GSK Investigational Site
  - Kurralta Park, South Australia, Australia, 5037
    - GSK Investigational Site
- Victoria
  - Fitzroy, Victoria, Australia, 3065
    - GSK Investigational Site
  - Prahran, Victoria, Australia, 3181
    - GSK Investigational Site
- Western Australia
  - Fremantle, Western Australia, Australia, 6160
    - GSK Investigational Site
Austria
- - Hall in Tirol, Austria, 6060
    - GSK Investigational Site
  - Linz, Austria, A-4021
    - GSK Investigational Site
  - Wien, Austria, 1050
    - GSK Investigational Site
  - Wien, Austria, 1090
    - GSK Investigational Site
Belgium
- - Bonheiden, Belgium, 2820
    - GSK Investigational Site
  - Brussels, Belgium, 1000
    - GSK Investigational Site
  - Brussels, Belgium, 1200
    - GSK Investigational Site
  - Edegem, Belgium, 2650
    - GSK Investigational Site
  - Gent, Belgium, 9000
    - GSK Investigational Site
  - Kortrijk, Belgium, 8500
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Roeselare, Belgium, 8800
    - GSK Investigational Site
Canada
- - Quebec, Canada, G1S 4L8
    - GSK Investigational Site
  - Quebec, Canada, G3K 2P8
    - GSK Investigational Site
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - GSK Investigational Site
  - Edmonton, Alberta, Canada, T6G 2X8
    - GSK Investigational Site
- British Columbia
  - Abbotsford, British Columbia, Canada, V2S 3N5
    - GSK Investigational Site
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - GSK Investigational Site
  - Victoria, British Columbia, Canada, V8V 3M9
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1R9
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - GSK Investigational Site
- Ontario
  - Hamilton, Ontario, Canada, L8N 4A6
    - GSK Investigational Site
  - Hamilton, Ontario, Canada, L8S 4K1
    - GSK Investigational Site
  - Kingston, Ontario, Canada, K7L 5G2
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 5A5
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 5W9
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1H 1A2
    - GSK Investigational Site
  - Richmond Hill, Ontario, Canada, L4B 3P8
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5G 1X5
    - GSK Investigational Site
- Quebec
  - Levis, Quebec, Canada, G6V 3Z1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3A 1A1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3T 1E2
    - GSK Investigational Site
Czechia
- - Brno, Czechia, 625 00
    - GSK Investigational Site
  - Hradec Králové, Czechia, 500 12
    - GSK Investigational Site
  - Olomouc, Czechia, 77520
    - GSK Investigational Site
  - Ostrava - Vitkovice, Czechia, 70384
    - GSK Investigational Site
  - Praha 10, Czechia, 100 34
    - GSK Investigational Site
  - Praha 4, Czechia, 140 21
    - GSK Investigational Site
  - Praha 7, Czechia, 17004
    - GSK Investigational Site
  - Praha 9, Czechia, 190 61
    - GSK Investigational Site
Denmark
- - Aalborg, Denmark, 9000
    - GSK Investigational Site
  - Aarhus, Denmark, 8000
    - GSK Investigational Site
  - Herlev, Denmark, 2730
    - GSK Investigational Site
  - Hvidovre, Denmark, 2650
    - GSK Investigational Site
  - Odense, Denmark, 5000
    - GSK Investigational Site
France
- - Amiens cedex 1, France, 80054
    - GSK Investigational Site
  - Clichy cedex, France, 92118
    - GSK Investigational Site
  - Lille cedex, France, 59037
    - GSK Investigational Site
  - Nantes cedex 1, France, 44093
    - GSK Investigational Site
  - Nice cedex 3, France, 06202
    - GSK Investigational Site
  - Paris cedex 10, France, 75475
    - GSK Investigational Site
  - Pessac cedex, France, 33604
    - GSK Investigational Site
  - Saint-Priest en Jarez, France, 42270
    - GSK Investigational Site
  - Vandoeuvre Les Nancy, France, 54511
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10117
    - GSK Investigational Site
  - Berlin, Germany, 13353
    - GSK Investigational Site
  - Berlin, Germany, 12157
    - GSK Investigational Site
  - Hamburg, Germany, 20148
    - GSK Investigational Site
  - Hamburg, Germany, 22559
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Freiburg, Baden-Wuerttemberg, Germany, 79106
    - GSK Investigational Site
  - Ulm, Baden-Wuerttemberg, Germany, 89081
    - GSK Investigational Site
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60590
    - GSK Investigational Site
- Niedersachsen
  - Braunschweig, Niedersachsen, Germany, 38126
    - GSK Investigational Site
  - Brinkum/Stuhr, Niedersachsen, Germany, 28816
    - GSK Investigational Site
  - Hannover, Niedersachsen, Germany, 30625
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Koeln, Nordrhein-Westfalen, Germany, 50937
    - GSK Investigational Site
  - Minden, Nordrhein-Westfalen, Germany, 32423
    - GSK Investigational Site
  - Muenster, Nordrhein-Westfalen, Germany, 48149
    - GSK Investigational Site
  - Muenster, Nordrhein-Westfalen, Germany, 48159
    - GSK Investigational Site
- Rheinland-Pfalz
  - Ludwigshafen, Rheinland-Pfalz, Germany, 67067
    - GSK Investigational Site
- Sachsen-Anhalt
  - Dessau, Sachsen-Anhalt, Germany, 06847
    - GSK Investigational Site
  - Halle, Sachsen-Anhalt, Germany, 06120
    - GSK Investigational Site
- Thueringen
  - Jena, Thueringen, Germany, 07747
    - GSK Investigational Site
Hungary
- - Bekescsaba, Hungary, 5600
    - GSK Investigational Site
  - Budapest, Hungary, 1088
    - GSK Investigational Site
  - Szekszárd, Hungary, 7100
    - GSK Investigational Site
Israel
- - Haifa, Israel, 31096
    - GSK Investigational Site
  - Holon, Israel, 58100
    - GSK Investigational Site
  - Jerusalem, Israel, 91031
    - GSK Investigational Site
  - Jerusalem, Israel, 91120
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Petach Tikva, Israel, 49100
    - GSK Investigational Site
  - Tel Aviv, Israel, 64239
    - GSK Investigational Site
Italy
- - Genova, Italy, 16132
    - GSK Investigational Site
  - Modena, Italy, 41100
    - GSK Investigational Site
  - Roma, Italy, 00152
    - GSK Investigational Site
  - Roma, Italy, 00168
    - GSK Investigational Site
- Sicilia
  - Palermo, Sicilia, Italy, 90127
    - GSK Investigational Site
Japan
- - Aichi, Japan, 460-0012
    - GSK Investigational Site
  - Aichi, Japan, 466-8560
    - GSK Investigational Site
  - Chiba, Japan, 285-8741
    - GSK Investigational Site
  - Fukuoka, Japan, 812-8582
    - GSK Investigational Site
  - Fukuoka, Japan, 818-8502
    - GSK Investigational Site
  - Hokkaido, Japan, 060-0033
    - GSK Investigational Site
  - Hyogo, Japan, 663-8501
    - GSK Investigational Site
  - Kagoshima, Japan, 892-0846
    - GSK Investigational Site
  - Kagoshima, Japan, 892-8512
    - GSK Investigational Site
  - Miyagi, Japan, 981-3213
    - GSK Investigational Site
  - Osaka, Japan, 530-0011
    - GSK Investigational Site
  - Osaka, Japan, 545-8586
    - GSK Investigational Site
  - Tokyo, Japan, 160-8582
    - GSK Investigational Site
  - Tokyo, Japan, 169-0073
    - GSK Investigational Site
  - Tokyo, Japan, 113-8519
    - GSK Investigational Site
Korea, Republic of
- - Daegu, Korea, Republic of, 705-717
    - GSK Investigational Site
  - Pusan, Korea, Republic of, 602-739
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 120-752
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 130-702
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-230
    - GSK Investigational Site
  - Wonju, Korea, Republic of, 220701
    - GSK Investigational Site
Netherlands
- - Almere, Netherlands, 1315 RA
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1105 AZ
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1091 AC
    - GSK Investigational Site
  - EDE, Netherlands, 6716 RP
    - GSK Investigational Site
  - Heerlen, Netherlands, 6419 PC
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3015 CE
    - GSK Investigational Site
New Zealand
- - Auckland, New Zealand, 1148
    - GSK Investigational Site
  - Dunedin, New Zealand, 9054
    - GSK Investigational Site
  - Hamilton, New Zealand, 3204
    - GSK Investigational Site
  - Lower Hutt, New Zealand, 6007
    - GSK Investigational Site
  - Otahuhu, New Zealand, 1640
    - GSK Investigational Site
  - Tauranga., New Zealand, 3143
    - GSK Investigational Site
Norway
- - Bodø, Norway, 8005
    - GSK Investigational Site
  - Oslo, Norway, N-0456
    - GSK Investigational Site
  - Tromsø, Norway, 9038
    - GSK Investigational Site
  - Trondheim, Norway, 7030
    - GSK Investigational Site
  - Tønsberg, Norway, 3116
    - GSK Investigational Site
  - Ålesund, Norway, 6017
    - GSK Investigational Site
Poland
- - Bydgoszcz, Poland, 85-168
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-681
    - GSK Investigational Site
  - Elblag, Poland, 82-300
    - GSK Investigational Site
  - Lublin, Poland, 20-607
    - GSK Investigational Site
  - Sopot, Poland, 81-756
    - GSK Investigational Site
  - Torun, Poland, 87-100
    - GSK Investigational Site
  - Wroclaw, Poland, 53-333
    - GSK Investigational Site
Slovakia
- - Bratislava, Slovakia, 831 04
    - GSK Investigational Site
  - Bratislava, Slovakia, 851 01
    - GSK Investigational Site
  - Bratislava, Slovakia, 851 07
    - GSK Investigational Site
  - Nitra, Slovakia, 949 01
    - GSK Investigational Site
  - Nove Mesto nad Vahom, Slovakia, 915 01
    - GSK Investigational Site
  - Presov, Slovakia, 080 01
    - GSK Investigational Site
  - Trnava, Slovakia, 917 02
    - GSK Investigational Site
South Africa
- - Bellville, South Africa, 7530
    - GSK Investigational Site
  - Claremont, South Africa, 7708
    - GSK Investigational Site
  - Observatory, South Africa, 7925
    - GSK Investigational Site
  - Parktown, South Africa, 2192
    - GSK Investigational Site
Spain
- - Badalona, Spain, 08916
    - GSK Investigational Site
  - Elche, Spain, 03293
    - GSK Investigational Site
  - Galdakao/Vizcaya, Spain, 48960
    - GSK Investigational Site
  - Madrid, Spain, 28046
    - GSK Investigational Site
  - Sabadell (Barcelona), Spain, 08208
    - GSK Investigational Site
Sweden
- - Göteborg, Sweden, SE-416 85
    - GSK Investigational Site
  - Lund, Sweden, SE-221 85
    - GSK Investigational Site
  - Stockholm, Sweden, SE-171 76
    - GSK Investigational Site
  - Stockholm, Sweden, SE-182 88
    - GSK Investigational Site
  - Umeå, Sweden, SE-901 85
    - GSK Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - GSK Investigational Site
  - Bristol, United Kingdom, BS2 8HW
    - GSK Investigational Site
  - Edinburgh, United Kingdom, EH4 2XU
    - GSK Investigational Site
  - Manchester, United Kingdom, M13 9WL
    - GSK Investigational Site
  - Newcastle-upon-Tyne, United Kingdom, NE1 4LP
    - GSK Investigational Site
  - Nottingham, United Kingdom, NG7 2UH
    - GSK Investigational Site
  - Oxford, United Kingdom, OX3 9DU
    - GSK Investigational Site
  - Salford, United Kingdom, M6 8HD
    - GSK Investigational Site
- Middlesex
  - Harrow, Middlesex, United Kingdom, HA1 3UJ
    - GSK Investigational Site
United States
- Arizona
  - Little Rock, Arizona, United States, 72205
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85712
    - GSK Investigational Site
- California
  - Anaheim, California, United States, 92801
    - GSK Investigational Site
  - Los Angeles, California, United States, 90015
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Francisco, California, United States, 94115
    - GSK Investigational Site
- Colorado
  - Lakewood, Colorado, United States, 80215
    - GSK Investigational Site
  - Littleton, Colorado, United States, 80120
    - GSK Investigational Site
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - GSK Investigational Site
- Florida
  - Jacksonville, Florida, United States, 32256-6004
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32207
    - GSK Investigational Site
  - Maitland, Florida, United States, 32751
    - GSK Investigational Site
  - Port Orange, Florida, United States, 32127
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342-5006
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - GSK Investigational Site
  - Oak Lawn, Illinois, United States, 60453
    - GSK Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40536-0298
    - GSK Investigational Site
- Louisiana
  - Hammond, Louisiana, United States, 70403
    - GSK Investigational Site
  - Monroe, Louisiana, United States, 71201
    - GSK Investigational Site
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - GSK Investigational Site
  - Towson, Maryland, United States, 21204
    - GSK Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109-5048
    - GSK Investigational Site
  - Chesterfield, Michigan, United States, 48047
    - GSK Investigational Site
  - Troy, Michigan, United States, 48098
    - GSK Investigational Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - GSK Investigational Site
  - Tupelo, Mississippi, United States, 38801
    - GSK Investigational Site
- Missouri
  - Lee's Summit, Missouri, United States, 64064
    - GSK Investigational Site
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - GSK Investigational Site
- New Jersey
  - Egg Harbor City, New Jersey, United States, 08234
    - GSK Investigational Site
  - Voorhees, New Jersey, United States, 08043
    - GSK Investigational Site
- New York
  - Great Neck, New York, United States, 11021
    - GSK Investigational Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - GSK Investigational Site
  - Durham, North Carolina, United States, 27710
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27612
    - GSK Investigational Site
- Ohio
  - Columbus, Ohio, United States, 43215
    - GSK Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74135
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, United States, 97225
    - GSK Investigational Site
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37212-1610
    - GSK Investigational Site
- Texas
  - Austin, Texas, United States, 78745
    - GSK Investigational Site
  - Houston, Texas, United States, 77034-0550
    - GSK Investigational Site
  - Pasadena, Texas, United States, 77505
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
- Washington
  - Seattle, Washington, United States, 98101
    - GSK Investigational Site
  - Seattle, Washington, United States, 98195
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo orally administered	Drug: Placebo Placebo capsules, administered orally for 12 weeks
Experimental: GSK1605786A 500mg once daily orally administered	Drug: GSK1605786A 500 mg twice daily, administered orally for 12 weeks Drug: GSK1605786A 500 mg once daily, administered orally for 12 weeks
Experimental: GSK1605786A 500mg twice daily orally administered	Drug: GSK1605786A 500 mg twice daily, administered orally for 12 weeks Drug: GSK1605786A 500 mg once daily, administered orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12 Time Frame: 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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With CDAI Remission at Week 12 Time Frame: 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.	Week 12
Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12 Time Frame: At Week 8 and 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.	At Week 8 and 12
Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12 Time Frame: Week 8 and 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.	Week 8 and 12
Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8 Time Frame: 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.	Week 8
Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8 Time Frame: 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.	Week 8
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12 Time Frame: Baseline (Week 0), Week 8 and Week 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.	Baseline (Week 0), Week 8 and Week 12
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) Time Frame: Up to Week 12	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.	Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2010

Primary Completion (Actual)

July 11, 2013

Study Completion (Actual)

July 11, 2013

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

114151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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First Submitted

First Submitted That Met QC Criteria

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Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Crohn's Disease

Clinical Trials on Placebo

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