Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis
- Conditions
- lcerative ColitisMedDRA version: 14.1Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-002013-19-IT
- Lead Sponsor
- Sanofi aventis Recherche&Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 93
o Male or Female =18 and =70 years old
o History of active ulcerative colitis of at least 3 months duration
o Active UC should be confirmed by colonoscopy or flexible sigmoidoscopy during the screening period within 7 days prior to randomization.
o 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-TNFs:
o 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
o TNF-alpha antagonists: Patient must have had an inadequate response or lost response or be intolerant to TNF-alpha antagonists
o Fecal calprotectin =200mg/kg
o Patients on corticosteroids must be on a stable dose =2 weeks prior to screening
o 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
o Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for =4 weeks prior to screening
o Patients naïve to anti-TNF alpha or non responder (primary or secondary) or intolerant to anti-TNF alpha
o Signed written informed consent
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 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
o Patients with Crohn's Disease (CD)
o Diagnosis of indeterminate colitis
o 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.
o Patients with prior colectomy or anticipated colectomy during their participation in the study
o Presence of ileal pouch or ostomy
o Fulminant disease or toxic megacolon
o Colonic dysplasia except for adenoma
o Total Parenteral Nutrition (TPN)
o Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus within 2 months prior to screening
o Previous exposure to natalizumab (Tysabri®) or vedolizumab
o Antidiarrheals within 2 weeks prior to screening
o Prednisone >40 mg/day (or equivalent)
o Budesonide >9 mg/day
o Received intravenous corticosteroids within 2 weeks prior to screening or during screening
o Rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening
o Received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening
o Antibiotics for UC or gastrointestinal infection within 4 weeks prior to screening
o Patient who has previously participated in any clinical trial of GBR500 / SAR339658
o Patient who has taken other investigational medications within 2 months or 5 half lives, (whichever is longer) prior to screening
o Use of any biologics for the treatment of UC in the previous 8 weeks before screening
o Requirement for concomitant treatment that could bias primary evaluation
o Pregnant or breast-feeding women
o Women of childbearing potential not protected by highly effective contraceptive method of birth control
o Patient with latent or active tuberculosis (TB)
o Any signs or symptoms suggestive of active TB upon medical history or clinical examination
o Patients with a positive QuantiFERON TB Gold Test (This test can be repeated once if indeterminate or believed to be a false positive)
o 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
o Patients with close contact with a person with active tuberculosis
o Patient with a history of listeriosis or tuberculosis (unless it is documented by a specialist that they were adequately treated previously or were given prophylactic treatment and can now start treatment with biologics)
o Administration of any live (attenuated) vaccine within 3 months prior to the screening Visit (eg, varicella-zoster vaccine, oral polio, rabies).
o Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit.
o Prior opportunistic infections within six months prior to screening or while receiving anti-TNF treatment
o History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
o 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 PML
o Patients with bleeding disorders or known platelet dysfunction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of SAR339658;Secondary Objective: To assess the safety of SAR339658;Primary end point(s): Proportion of Participants with Clinical Response by Mayo Score;Timepoint(s) of evaluation of this end point: At Week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of Participants with Clinical Remission by Mayo Score<br>Proportion of Participants with Mucosal Healing<br>Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)<br>Change from Baseline in Quality of Life (QoL) SF-36<br>Change from Baseline in the partial Mayo Score<br>Number of Participants with adverse events;Timepoint(s) of evaluation of this end point: At Week 8<br>At Week 8<br>At Weeks 4 and 8<br>At Weeks 4 and 8<br>At Weeks 4 and 6<br>Up to Week 18