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

• Status: Terminated
• Trial end date: 2013-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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