One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Rifaximin EIR; Placebo
Intervention description: Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.; Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Rifaximin; Clinical remission with endoscopic response; Inflammatory Bowel Disease

Summary:

      The primary objective is to determine the efficacy of rifaximin DR also referred to as
      Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission
      and endoscopic response following 16 weeks of treatment in participants presenting with
      active moderate Crohn's disease. A key secondary objective is to evaluate clinical and
      endoscopic remission following an additional 36 weeks of treatment.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Moderate, non-fistulizing Crohn's disease in the ileum and/or colon prior to
             randomization; and a SES-CD score of ≥7 (confirmed by centralized endoscopy reading).

          -  During the screening period, the participant will need to have certain average daily
             scores for abdominal pain and average number of liquid/very soft stools.

        Major Exclusion Criteria:

          -  Pregnant or lactating females. Females of childbearing (reproductive) potential must
             have a negative serum pregnancy test at screening and agree to use a highly effective
             method(s) of contraception throughout their participation in the study. Diagnosis of
             ulcerative or indeterminate colitis.

          -  Diagnosis of Celiac Disease.

          -  Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed
             likely for Crohn's disease during the study period.

          -  Presence of an ileostomy or colostomy.

          -  Known fixed symptomatic stenosis/stricture of the small or large bowel.

          -  Had more than one segmental colonic resection.

          -  Had more than 3 small bowel resections or symptoms associated with short bowel
             syndrome.

          -  Current evidence of peritonitis.

          -  History or evidence of colonic mucosal dysplasia.

          -  History or evidence of adenomatous colonic polyps that have not been removed.

          -  Unwilling to be tapered off corticosteroids by Week 8 or the participant is known by
             the Investigator to be steroid-dependent.

          -  Has used a biologic within 12 weeks of randomization.

          -  Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs
             within 8 weeks prior to randomization.

          -  Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroid
             enemas/foams/ suppositories within 2 weeks prior to screening visit.