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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658

Key facts

Study ID

NCT01659138

Run by

Sanofi

People needed

28

Starts

2012-08-01

Expected to finish

2016-04-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female ≥18 and ≤70 years old
• History of active ulcerative colitis of at least 3 months duration
• Active UC should be confirmed by colonoscopy or flexible sigmoidoscopy during the screening period within 7 days prior to randomization.
• Moderate to severe ulcerative colitis at time of screening, confirmed by Mayo score ≥6 to 12 and endoscopy subscore of ≥2 despite treatment with immunosuppressants and/or anti-tumor necrosis factors (TNFs):
• Immunosuppressants: Patient must be on concurrent treatment with or have had an inadequate response to (did not respond to or lost response to) or be intolerant to immunosuppressants such as azathioprine, 6-mercaptopurine, or methotrexate.
• AND/OR
• TNF-alpha antagonists: Patient must have had an inadequate response or lost response or be intolerant to TNF-alpha antagonists
• Fecal calprotectin ≥200mg/kg
• Patients on corticosteroids must be on a stable dose ≥2 weeks prior to screening
• Patients on azathioprine, 6- mercaptopurine or methotrexate must be on treatment for at least 12 weeks prior to screening; and on a stable dose ≥4 weeks prior to screening
• Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥4 weeks prior to screening
• Patients naïve to anti-TNF alpha or non-responder (primary or secondary) or intolerant to anti-TNF alpha
• Signed written informed consent

You may not qualify if…

• 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

Where it is running

• Investigational Site Number 840065 — Sun City, Arizona, United States
• Investigational Site Number 840059 — Mission Hills, California, United States
• Investigational Site Number 840074 — San Diego, California, United States
• Investigational Site Number 840061 — Littleton, Colorado, United States
• Investigational Site Number 840003 — Miami, Florida, United States
• Investigational Site Number 840008 — Miramar, Florida, United States
• Investigational Site Number 840048 — Winter Park, Florida, United States
• Investigational Site Number 840053 — Savannah, Georgia, United States
• Investigational Site Number 840001 — Chicago, Illinois, United States
• Investigational Site Number 840005 — Oak Lawn, Illinois, United States
• Investigational Site Number 840078 — Hammond, Louisiana, United States
• Investigational Site Number 840070 — Rochester Hills, Michigan, United States
• Investigational Site Number 840060 — Ocean Springs, Mississippi, United States
• Investigational Site Number 840024 — Mexico, Missouri, United States
• Investigational Site Number 840051 — Great Neck, New York, United States
• Investigational Site Number 840071 — Rochester, New York, United States
• Investigational Site Number 840089 — Winston-Salem, North Carolina, United States
• Investigational Site Number 840046 — Cincinnati, Ohio, United States
• Investigational Site Number 840045 — Phoenixville, Pennsylvania, United States
• Investigational Site Number 840019 — Pasadena, Texas, United States
• Investigational Site Number 840088 — San Antonio, Texas, United States
• Investigational Site Number 840038 — Sugar Land, Texas, United States
• Investigational Site Number 840068 — Charlottesville, Virginia, United States
• Investigational Site Number 840034 — Seattle, Washington, United States
• Investigational Site Number 840064 — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.