Ulcerative Colitis Clinical Trial
— FUSCIAOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)
Verified date | July 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Primary Objective:
To assess the efficacy of SAR339658
Secondary Objective:
To assess the safety of SAR339658
Status | Terminated |
Enrollment | 28 |
Est. completion date | April 2016 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion criteria: - 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 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Investigational Site Number 040003 | Innsbruck | |
Canada | Investigational Site Number 124002 | Vancouver | |
France | Investigational Site Number 250003 | Grenoble | |
France | Investigational Site Number 250006 | Vandoeuvre Les Nancy | |
Germany | Investigational Site Number 276001 | Berlin | |
Germany | Investigational Site Number 276005 | Hamburg | |
Germany | Investigational Site Number 276007 | Hamburg | |
Italy | Investigational Site Number 380003 | Firenze | |
Italy | Investigational Site Number 380006 | San Giovanni Rotondo | |
Poland | Investigational Site Number 616001 | Gdynia | |
Poland | Investigational Site Number 616002 | Lodz | |
Poland | Investigational Site Number 616004 | Lodz | |
Poland | Investigational Site Number 616005 | Lodz | |
Poland | Investigational Site Number 616007 | Poznan | |
Poland | Investigational Site Number 616006 | Sroda Wielkopolska | |
Poland | Investigational Site Number 616008 | Warszawa | |
United States | Investigational Site Number 840068 | Charlottesville, | Virginia |
United States | Investigational Site Number 840001 | Chicago | Illinois |
United States | Investigational Site Number 840046 | Cincinnati | Ohio |
United States | Investigational Site Number 840051 | Great Neck | New York |
United States | Investigational Site Number 840078 | Hammond | Louisiana |
United States | Investigational Site Number 840061 | Littleton | Colorado |
United States | Investigational Site Number 840024 | Mexico | Missouri |
United States | Investigational Site Number 840003 | Miami | Florida |
United States | Investigational Site Number 840008 | Miramar, | Florida |
United States | Investigational Site Number 840059 | Mission Hills | California |
United States | Investigational Site Number 840005 | Oak Lawn | Illinois |
United States | Investigational Site Number 840060 | Ocean Springs | Mississippi |
United States | Investigational Site Number 840019 | Pasadena, | Texas |
United States | Investigational Site Number 840045 | Phoenixville | Pennsylvania |
United States | Investigational Site Number 840071 | Rochester | New York |
United States | Investigational Site Number 840070 | Rochester Hills | Michigan |
United States | Investigational Site Number 840088 | San Antonio | Texas |
United States | Investigational Site Number 840074 | San Diego | California |
United States | Investigational Site Number 840053 | Savannah, | Georgia |
United States | Investigational Site Number 840034 | Seattle | Washington |
United States | Investigational Site Number 840038 | Sugar Land | Texas |
United States | Investigational Site Number 840065 | Sun City | Arizona |
United States | Investigational Site Number 840064 | Wauwatosa | Wisconsin |
United States | Investigational Site Number 840089 | Winston Salem | North Carolina |
United States | Investigational Site Number 840048 | Winter Park, | Florida |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Austria, Canada, France, Germany, Italy, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Participants with Clinical Response by Mayo Score | At Week 8 | No | |
Secondary | Proportion of Participants with Clinical Remission by Mayo Score | At Week 8 | No | |
Secondary | Proportion of Participants with Mucosal Healing | At Week 8 | No | |
Secondary | Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) | At Weeks 4 and 8 | No | |
Secondary | Change from Baseline in Quality of Life (QoL) SF-36 | At Weeks 4 and 8 | No | |
Secondary | Change from Baseline in the partial Mayo Score | At Weeks 4 and 6 | No | |
Secondary | Number of Participants with adverse events | Up to Week 17 | Yes |
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