GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: GSK1605786A; Placebo; GSK1605786A
Intervention description: GSK1605786A 500 milligrams once daily; Placebo; GSK1605786A 500 milligrams twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

Summary:

      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.
    

Eligibility criteria:

        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