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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01659138
First received: August 3, 2012
Last updated: August 25, 2014
Last verified: August 2014

August 3, 2012
August 25, 2014
August 2012
April 2016   (final data collection date for primary outcome measure)
Proportion of Participants with Clinical Response by Mayo Score [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01659138 on ClinicalTrials.gov Archive Site
  • Proportion of Participants with Clinical Remission by Mayo Score [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Mucosal Healing [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
  • Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: At Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Change from Baseline in Quality of Life (QoL) SF-36 [ Time Frame: At Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Change from Baseline in the partial Mayo Score [ Time Frame: At Weeks 4 and 6 ] [ Designated as safety issue: No ]
  • Number of Participants with adverse events [ Time Frame: Up to Week 17 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)

Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

The total duration of study period is 18 weeks, broken down as follows: - 4 weeks for screening - 8 weeks for treatment - 6 weeks for the post treatment safety follow-up A post-study long term safety follow-up will be performed in the form of a phone interview at 3, 6, 12, 18 and 24 months from the last administration of the study medication. After completion of the 8-week treatment phase of this study, patients may be eligible to enter a long term safety study (LTS12593) for active treatment with SAR339658.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: SAR339658
    Pharmaceutical form:solution Route of administration: intravenous
  • Other: Placebo
    Pharmaceutical form:solution Route of administration: intravenous
  • Experimental: SAR339658
    Dose regimen every 2 weeks
    Intervention: Drug: SAR339658
  • Placebo Comparator: Placebo
    Placebo every 2 weeks
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
93
April 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion criteria: 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 Exclusion criteria: 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 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 that they were adequately treated) 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   France,   Germany,   Italy,   Poland
 
NCT01659138
ACT12688, 2012-002013-19, U1111-1124-1076
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP