Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis

Exclusion Criteria

• •Patients with Crohn's Disease
• •Diagnosis of indeterminate colitis
• •Patients with stool sample positive for ova, parasites, or positive culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E. Coli spp. or positive for Clostridium difficile B toxin in stools.
• •Patients with prior colectomy or anticipated colectomy during their participation in the study
• •Presence of ileal pouch or ostomy
• •Fulminant disease or toxic megacolon
• •Colonic dysplasia except for adenoma
• •Total Parenteral Nutrition
• •Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus within 2 months prior to screening
• •Previous exposure to natalizumab (Tysabri®) or vedolizumab
• •Antidiarrheals within 2 weeks prior to screening
• •Prednisone \>40 mg/day (or equivalent)
• •Budesonide \>9 mg/day
• •Received intravenous corticosteroids within 2 weeks prior to screening or during screening
• •Rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening
• •Received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening
• •Antibiotics for ulcerative colitis or gastrointestinal infection within 4 weeks prior to screening
• •Patient who has previously participated in any clinical trial of GBR500 / SAR339658
• •Patient who has taken other investigational medications within 2 months or 5 half lives, (whichever is longer) prior to screening
• •Use of any biologics for the treatment of ulcerative colitis in the previous 8 weeks before screening
• •Requirement for concomitant treatment that could bias primary evaluation
• •Pregnant or breast-feeding women
• •Women of childbearing potential not protected by highly effective contraceptive method of birth control
• •Patient with latent or active tuberculosis (TB) defined as:
• •* Any signs or symptoms suggestive of active TB upon medical history or clinical examination
• •* Patients with a positive QuantiFERON TB Gold Test
• •* Chest radiograph within 3 months prior to the inclusion visit consistent with prior tuberculosis infection including, but not limited to, apical scarring, apical fibrosis, or multiple calcified granulomasa. This does not include non-caseating granulomasa
• •* Patients with close contact with a person with active tuberculosis
• •Patient with a history of listeriosis or tuberculosis (unless it is documented that they were adequately treated)
• •Administration of any live (attenuated) vaccine within 3 months prior to the screening Visit (eg, varicella-zoster vaccine, oral polio, rabies)
• •Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
• •Prior opportunistic infections within 6 months prior to screening or while receiving anti-TNF treatment
• •History of a hypersensitivity reaction, other than localized injection site reaction, to any biological molecule
• •History or any current signs of demyelinating disease or any neurological disease that can by the opinion of Investigator interfere with study safety assessments including assessment for progressive multifocal leukoencephalopathy
• •Patients with bleeding disorders or known platelet dysfunction
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.