GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:May 2011
End Date:April 2015
Contact:US GSK Clinical Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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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.


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disease worsening and require additional (rescue) treatment will be withdrawn and may be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.

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
We found this trial at
25
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Jacksonville, Florida 32207
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Anaheim, California 92807
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Boston, Massachusetts 02115
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Chesterfield, Missouri 63017
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Cincinnati, Ohio 45229
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Durham, North Carolina 27705
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Glendale, Arizona 85304
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Grand Rapids, Michigan 49546
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Joliet, Illinois 60435
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Kennewick, Washington 99336
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Klamath Falls, Oregon 97601
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Knoxville, Tennessee 37916
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La Crosse, Wisconsin 54601
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Louisville, Kentucky 40202
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New Haven, Connecticut 06520
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New York, New York 10032
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Philadelphia, Pennsylvania 19104
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Richmond, Virginia 23298
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Rochester, Minnesota 55905
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Roswell, Georgia 30076
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Salt Lake City, Utah 84132
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Weatherford, Oklahoma 73096
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