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: April 16, 2014
Last verified: April 2014
  Purpose

Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658


Condition Intervention Phase
Ulcerative Colitis
Drug: SAR339658
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of Participants with Clinical Response by Mayo Score [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 93
Study Start Date: August 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR339658
Dose regimen every 2 weeks
Drug: SAR339658
Pharmaceutical form:solution Route of administration: intravenous
Placebo Comparator: Placebo
Placebo every 2 weeks
Other: Placebo
Pharmaceutical form:solution Route of administration: intravenous

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659138

  Show 68 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01659138     History of Changes
Other Study ID Numbers: ACT12688, 2012-002013-19, U1111-1124-1076
Study First Received: August 3, 2012
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014