GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease (SHIELD-2)

August 7, 2017 updated by: GlaxoSmithKline

A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

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 in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

Study Overview

Status

Terminated

Conditions

Crohn's Disease

Intervention / Treatment

Detailed Description

This is a multi-centre, randomised, placebo-controlled, double-blind parallel group study in adult subjects with Crohn's disease who previously achieved clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior Phase III induction study (Study CCX114151 or another GSK sponsored induction study). Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo. Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule. Subjects who complete the treatment period may be eligible to enter an open-label extension study. Subjects who experience disease worsening and require additional (rescue) treatment will be withdrawn and may be eligible to enter the open-label study. Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment. Approximately 756 subjects will be enrolled.

Study Type

Interventional

Enrollment (Actual)

229

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
  - Box Hill, Victoria, Australia, 3128
    - GSK Investigational Site
  - 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
  - Oberpullendorf, Austria, 7350
    - GSK Investigational Site
  - St.Veit/Glan, Austria, 9300
    - GSK Investigational Site
  - Wien, Austria, 1030
    - 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
  - Gent, Belgium, 9000
    - GSK Investigational Site
  - Kortrijk, Belgium, 8500
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Roeselare, Belgium, 8800
    - GSK Investigational Site
Bulgaria
- - Plovdiv, Bulgaria, 4002
    - GSK Investigational Site
  - Sofia, Bulgaria, 1431
    - GSK Investigational Site
  - Sofia, Bulgaria, 1407
    - GSK Investigational Site
  - Sofia, Bulgaria, 1527
    - GSK Investigational Site
  - Varna, Bulgaria, 9010
    - 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
- 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 3Z5
    - GSK Investigational Site
  - Hamilton, Ontario, Canada, L8N 4A6
    - 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
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3T 1E2
    - GSK Investigational Site
Chile
- - Vina del Mar, Chile, 2520012
    - GSK Investigational Site
Czechia
- - 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, 2605
    - GSK Investigational Site
  - Odense, Denmark, 5000
    - GSK Investigational Site
Estonia
- - Tallinn, Estonia, 10617
    - GSK Investigational Site
  - Tallinn, Estonia, EE-10138
    - GSK Investigational Site
  - Tartu, Estonia, 51014
    - GSK Investigational Site
France
- - 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
  - Hamburg, Germany, 20148
    - GSK Investigational Site
  - Hamburg, Germany, 22559
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Ulm, Baden-Wuerttemberg, Germany, 89081
    - GSK Investigational Site
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60590
    - GSK Investigational Site
- Niedersachsen
  - Brinkum/Stuhr, Niedersachsen, Germany, 28816
    - GSK Investigational Site
  - Hannover, Niedersachsen, Germany, 30625
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Minden, Nordrhein-Westfalen, Germany, 32423
    - GSK Investigational Site
Hong Kong
- - Hong Kong, Hong Kong
    - GSK Investigational Site
  - Shatin, New Territories, Hong Kong
    - GSK Investigational Site
Hungary
- - Bekescsaba, Hungary, 5600
    - GSK Investigational Site
  - Budapest, Hungary, 1062
    - GSK Investigational Site
  - Budapest, Hungary, 1083
    - GSK Investigational Site
  - Budapest, Hungary, 1136
    - GSK Investigational Site
  - Debrecen, Hungary, 4025
    - GSK Investigational Site
  - Mosonmagyaróvár, Hungary, 9200
    - GSK Investigational Site
  - Szekszárd, Hungary, 7100
    - GSK Investigational Site
  - Vác, Hungary, 2600
    - GSK Investigational Site
Israel
- - Afula, Israel, 18101
    - GSK Investigational Site
  - Beer Sheva, Israel, 84101
    - GSK Investigational Site
  - 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
  - Petah Tikva, Israel, 49100
    - GSK Investigational Site
  - Ramat-Gan, Israel, 52621
    - GSK Investigational Site
  - Tel Aviv, Israel, 64239
    - GSK Investigational Site
  - Zerifin, Israel, 70300
    - 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
  - Chiba, Japan, 285-8741
    - GSK Investigational Site
  - Fukuoka, Japan, 812-8582
    - GSK Investigational Site
  - Fukuoka, Japan, 818-8502
    - GSK Investigational Site
  - Hiroshima, Japan, 720-8520
    - 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
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, 130702
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135710
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 138-736
    - GSK Investigational Site
  - Wonju, Korea, Republic of, 220701
    - GSK Investigational Site
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1081 HV
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1091 AC
    - GSK Investigational Site
  - EDE, Netherlands, 6716 RP
    - GSK Investigational Site
  - Eindhoven, Netherlands, 5623 EJ
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3015 CE
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3083 AN
    - GSK Investigational Site
New Zealand
- - Dunedin, New Zealand, 9054
    - GSK Investigational Site
  - Lower Hutt, New Zealand, 6007
    - GSK Investigational Site
  - Otahuhu, Auckland, New Zealand, 2025
    - GSK Investigational Site
  - Tauranga., New Zealand, 3143
    - GSK Investigational Site
Norway
- - Tromsø, Norway, 9038
    - GSK Investigational Site
  - Tønsberg, Norway, 3116
    - GSK Investigational Site
Poland
- - Bydgoszcz, Poland, 85-168
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-681
    - GSK Investigational Site
  - Lublin, Poland, 20-582
    - GSK Investigational Site
  - Sopot, Poland, 81-756
    - GSK Investigational Site
  - Torun, Poland, 87-100
    - GSK Investigational Site
  - Wroclaw, Poland, 53-333
    - GSK Investigational Site
Portugal
- - Lisboa, Portugal, 1649-035
    - GSK Investigational Site
  - Lisboa, Portugal, 1769-001
    - GSK Investigational Site
  - Porto, Portugal, 4099-001
    - GSK Investigational Site
  - Viseu, Portugal, 3504-509
    - GSK Investigational Site
Russian Federation
- - Irkutsk, Russian Federation, 664079
    - GSK Investigational Site
  - Kazan, Russian Federation, 420064
    - GSK Investigational Site
  - Lipetsk, Russian Federation, 398055
    - GSK Investigational Site
  - Moscow, Russian Federation, 129110
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603126
    - GSK Investigational Site
  - Rostov-on-Don, Russian Federation, 344091
    - GSK Investigational Site
  - Samara, Russian Federation, 443011
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 196247
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 197047
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634063
    - 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
  - Fuenlabrada (Madrid), Spain, 28942
    - GSK Investigational Site
  - Galdakao/Vizcaya, Spain, 48960
    - GSK Investigational Site
  - Madrid, Spain, 28006
    - GSK Investigational Site
  - Madrid, Spain, 28007
    - GSK Investigational Site
  - Madrid, Spain, 28040
    - GSK Investigational Site
  - Madrid, Spain, 28046
    - GSK Investigational Site
  - Marbella, Spain, 29600
    - GSK Investigational Site
  - Sabadell (Barcelona), Spain, 08208
    - GSK Investigational Site
  - Santander (Cantabria), Spain, 39008
    - GSK Investigational Site
Sweden
- - Lund, Sweden, SE-221 85
    - GSK Investigational Site
  - Stockholm, Sweden, SE-171 76
    - GSK Investigational Site
  - Stockholm, Sweden, SE-182 88
    - GSK Investigational Site
Switzerland
- - Bern, Switzerland, 3004
    - GSK Investigational Site
  - Zürich, Switzerland, 8091
    - GSK Investigational Site
Taiwan
- - Taichung, Taiwan, 40705
    - GSK Investigational Site
Turkey
- - Ankara, Turkey, 06100
    - GSK Investigational Site
Ukraine
- - Chernivtsi, Ukraine, 58005
    - GSK Investigational Site
  - Dnipropetrovsk, Ukraine, 49044
    - GSK Investigational Site
  - Donetsk, Ukraine, 83003
    - GSK Investigational Site
  - Donetsk, Ukraine, 83017
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61037
    - GSK Investigational Site
  - Kyiv, Ukraine
    - GSK Investigational Site
  - Odesa, Ukraine, 65117
    - GSK Investigational Site
  - Simferopol, Ukraine, 95017
    - GSK Investigational Site
  - Vinnytsya, Ukraine, 21029
    - 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
  - 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
  - La Jolla, California, United States, 92093
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Francisco, California, United States, 94115
    - GSK Investigational Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - GSK Investigational Site
  - 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
  - New Haven, Connecticut, United States, 06510
    - GSK Investigational Site
- District of Columbia
  - Washington, D.C., District of Columbia, United States, 20007
    - GSK Investigational Site
- Florida
  - Jacksonville, Florida, United States, 32256-6004
    - GSK Investigational Site
  - Port Orange, Florida, United States, 32127
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342-5006
    - GSK Investigational Site
  - Suwanee, Georgia, United States, 30024
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - 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
  - Towson, Maryland, United States, 21286
    - GSK Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109-5682
    - 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
- Missouri
  - Lee's Summit, Missouri, United States, 64064
    - GSK Investigational Site
  - Mexico, Missouri, United States, 65265-3726
    - GSK Investigational Site
- New York
  - Brooklyn, New York, United States, 11206
    - GSK Investigational Site
  - East Setauket, New York, United States, 11733-9292
    - GSK Investigational Site
  - Great Neck, New York, United States, 11021
    - GSK Investigational Site
  - Lake Success, New York, United States, 11042
    - GSK Investigational Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7080
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28207
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28209
    - 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
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - GSK Investigational Site
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37212-1610
    - GSK Investigational Site
- Utah
  - Ogden, Utah, United States, 84405
    - GSK Investigational Site
- Virginia
  - Christiansburg, Virginia, United States, 24073
    - GSK Investigational Site
  - Danville, Virginia, United States, 24541
    - GSK Investigational Site
  - Norfolk, Virginia, United States, 23502
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23249
    - GSK Investigational Site
- Washington
  - Seattle, Washington, United States, 98101
    - GSK Investigational Site
  - Seattle, Washington, United States, 98195
    - GSK Investigational Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53226
    - 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:

Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study
Written informed consent prior to any CCX114157 specific study procedures
Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent
Stable doses of Crohn's disease medications
Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study

Exclusion Criteria:

If female, is pregnant, has a positive pregnancy test or is breast-feeding
Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.
Known or suspected fixed symptomatic small bowel stricture
Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks
Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities

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	Drug: Placebo Placebo
Experimental: GSK1605786A once daily 500 milligrams once daily	Drug: GSK1605786A GSK1605786A 500 milligrams once daily Drug: GSK1605786A GSK1605786A 500 milligrams twice daily
Experimental: GSK1605786A twice daily 500 milligrams twice daily	Drug: GSK1605786A GSK1605786A 500 milligrams once daily Drug: GSK1605786A GSK1605786A 500 milligrams twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission (Crohn's Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period Time Frame: Week 28 and 52	Clinical remission is defined as a CDAI score <150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.	Week 28 and 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period Time Frame: Week 28 and 52	Clinical remission is defined as a CDAI score <150 points. A participant was considered to be not taking corticosteroids at Weeks 28 and 52 if the participant had not taken a corticosteroid for the 8 days prior to and the day of the CDAI assessment for each of Weeks 28 and 52. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period have been presented.	Week 28 and 52
Percentage of Participants in Clinical Remission at Both Weeks 28 and 52 of the 52-week Treatment Period Among Those Participants Who Were in Clinical Remission at Baseline Time Frame: Week 28 and 52	Clinical remission is defined as a CDAI score <150 points. Among participants in remission at baseline, the percentage of participants with clinical remission at both Weeks 28 and 52 of the treatment period using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher's exact test. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.	Week 28 and 52
Percentage of Participants in Clinical Remission at All Visits (Continuous Clinical Remission) During the 52-week Treatment Period Among Participants in Clinical Remission at Baseline Time Frame: Upto Week 52	The percentage of participants with clinical remission at all visits during the 52-week treatment period were to be summarized by treatment group for the subset of participants in remission at baseline, using the no effect imputation for missing data. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. Comparisons between each GSK1605786A dose group and placebo were to be made using Fisher's exact test.The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.	Upto Week 52
Percentage of Participants in Clinical Remission at Week 52 Time Frame: Week 52	The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.	Week 52
Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period Time Frame: Week 28 and 52	Clinical response is defined as a reduction from the induction study baseline CDAI score of >=100 points. The percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-week maintenance treatment period in the ITT population using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher's exact test. Participants with missing CDAI scores were to be considered non-responders according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.	Week 28 and 52
Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline Time Frame: Upto Week 52	The duration of time participants maintained clinical remission during the 52-week treatment period was to be defined as the time between Week 0 and the first visit where remission was not observed in those participants in remission at baseline. These time periods were to be summarized by treatment group using quartiles and their corresponding confidence intervals. Comparisons between each GSK1605786A dose group and placebo were to be made using log-rank tests. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.	Upto Week 52
Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52 Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52	The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores and changes in CDAI scores during the 52-week treatment period were to be summarized by treatment group at Weeks 4, 8, 12, 20, 28, 36, 44, and 52. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52 Time Frame: Baseline (Week 0) and Week 52	The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The IBDQ questionnaire was to be completed by each participant at baseline and at Weeks 28, and 52. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Week 52
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: Upto 56 weeks	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.	Upto 56 weeks
Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56 Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56	Vital sign assessments included SBP and DBP collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and Week 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56
Change From Baseline in Vital Sign Heart Rate Upto Week 56 Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56	Vital sign assessment included heart rate collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56
Number of Participants With Shift From Baseline in Hematology Parameters Time Frame: Upto Week 56	Hematology parameters included platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hematocrit, red blood cell count, hemoglobin, white blood cell count and segmented neutrophils . Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44 and 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in hematology parameters characterized as high and low have been presented.	Upto Week 56
Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Time Frame: Upto Week 56	Clinical chemistry parameters included total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma glutamyl transferase, total bilirubin, direct bilirubin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, blood urea nitrogen (BUN)/Urea, creatinine, uric acid, lactate dehydrogenase, bicarbonate, cholesterol and creatinine kinase. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in clinical chemistry parameters characterized as high and low have been presented.	Upto Week 56
Change From Baseline in Liver Function Test Parameter Total Bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. Time Frame: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.	Liver function test parameter included total bilirubin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.
Change From Baseline in Liver Function Test Parameter Albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56 Time Frame: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56	Liver function test parameter included albumin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Change From Baseline in Liver Function Test Parameter Alanine Amino Transferase, Aspartate Amino Transferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56 Time Frame: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56	Liver function test parameters included alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52 Time Frame: Week 28 and 52	A 12 lead ECG was collected at Weeks 28 and 52. ECG abnormalities were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). A-NCS data for Week 28 and 52 have been presented.	Week 28 and 52
Change From Baseline in Short Form - 36 Version 2 (SF-36 v2) at Weeks 28 and 52 Time Frame: Baseline (Week 0) and Weeks 28 and 52	The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 v2 items are scored such that a higher score indicates a better health state and better functioning. Data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 28 and 52
Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52 Time Frame: Baseline (Week 0) and Weeks 28 and 52	EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). Data for Change from Baseline in EuroQol five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 28 and 52
Change From Baseline in Work Productivity & Activity Impairment - Crohn's Disease (WPAI-CD) at Weeks 28 and 52 Time Frame: Baseline (Week 0) and Weeks 28 and 52	WPAI measures the effect of your CD on your ability to work and perform regular activities. 6-items assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID). Data for change from Baseline in WPAI-CD at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 28 and 52
Receipt of Disability Benefits at Weeks 28 and 52 Time Frame: Weeks 28 and 52	Receipt of disability benefits (Yes/No) was to be recorded at Weeks 0, 28 and 52 and Early Withdrawal visit if applicable. Change from baseline in receipt of disability benefits was to be compared between participants in remission versus participants not in remission using a Wilcoxon rank sum test. Data for Receipt of disability benefits at Weeks 28 and 52 was not collected following early termination of this study.	Weeks 28 and 52
Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52 Time Frame: Baseline (Week 0) and Weeks 28 and 52	Healthcare related resource utilization was to include: Hospitalizations (all cause and Crohn's disease related), Length of stay, Surgical procedures (all cause and Crohn's disease related), Outpatient visits (all cause and Crohn's disease related ). The frequency of hospitalizations, surgical procedures and hospital out-patient visits were to be recorded at Weeks 28 and 52. The number and percentage of participants reporting all cause and Crohn's disease -related hospitalizations, surgeries, and hospital out-patient visits were to be summarized and compared between each GSK1605786A dose group and placebo using Fisher's exact test. Data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 28 and 52
Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52 Time Frame: Baseline (Week 0 and Weeks 28 and 52	C-reactive protein (CRP) at was to be assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 visit if applicable. Data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0 and Weeks 28 and 52
Change From Baseline in Faecal Calprotectin at Weeks 28 and 52 Time Frame: Baseline (Week 0) and Weeks 28 and 52	Stool sample for faecal calprotectin were to be collected at Weeks 28 and 52 visit if applicable. Data for Change from baseline in faecal calprotectin at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.	Baseline (Week 0) and Weeks 28 and 52

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)

May 9, 2011

Primary Completion (Actual)

October 23, 2013

Study Completion (Actual)

October 23, 2013

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

Additional Relevant MeSH Terms

Other Study ID Numbers

114157
2010-022383-12 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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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More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Crohn's Disease

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