A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

INTERVENTION: Trade Name: Kremezin Product Name: AST‐120 Product Code: AST‐120 Pharmaceutical Form: Granules INN or Proposed INN: AST‐120 Current Sponsor code: AST‐120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon Concentration unit: g gram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use CONDITION: The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. PRIMARY OUTCOME: Main Objective: The objective of this study is to evaluate the safety and efficacy of AST‐120 in the treatment of mild to moderately severe fistulizing Crohn’s disease. Primary end point(s): The primary efficacy endpoint is treatment success in the therapy for mild to moderate Crohn’s disease with fistulas defined by: A reduction of at least 50% in the number of draining fistulas at both week 4 and week 8. ; ; The primary safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during 8 weeks of treatment. Secondary Objective: INCLUSION CRITERIA: 18 to 70 years of age Body Weight: (=40 kg) Documented diagnosis of Crohn’s disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis Presence of at least one draining perianal fistula. Patients with enterocutaneous fistulas can be included if they have = 1 draining perianal fistula. Women with rectovaginal fistulas are included if they have = 1 draining perianal fistula. Crohn’s Disease Activity Index (CDAI) score < 400 Platelet count (thrombocytes) =100,000/µL Able and willing to comply with all protocol procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range