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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01316939

Run by

GlaxoSmithKline

People needed

229

Starts

2011-05-09

Expected to finish

2013-10-23

Last updated by the study team

2017-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Aurora, Colorado, United States
• GSK Investigational Site — Lakewood, Colorado, United States
• GSK Investigational Site — Littleton, Colorado, United States
• GSK Investigational Site — Hamden, Connecticut, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Port Orange, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Suwanee, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Hammond, Louisiana, United States
• GSK Investigational Site — Monroe, Louisiana, United States
• GSK Investigational Site — Chevy Chase, Maryland, United States
• GSK Investigational Site — Towson, Maryland, United States
• GSK Investigational Site — Towson, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Little Rock, Arizona, United States

Full record on ClinicalTrials.gov

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