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
  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: April 2016
Estimated Primary Completion Date: April 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Investigational Site Number 840065
Sun City, Arizona, United States, 85351
United States, California
Investigational Site Number 840059
Mission Hills, California, United States, 91345
Investigational Site Number 840074
San Diego, California, United States, 92114
United States, Colorado
Investigational Site Number 840061
Littleton, Colorado, United States, 80120
United States, Florida
Investigational Site Number 840003
Miami, Florida, United States, 33136
Investigational Site Number 840008
Miramar,, Florida, United States, 33025
Investigational Site Number 840048
Winter Park,, Florida, United States, 32789
United States, Georgia
Investigational Site Number 840053
Savannah,, Georgia, United States, 31405
United States, Illinois
Investigational Site Number 840001
Chicago, Illinois, United States, 60637
Investigational Site Number 840005
Oak Lawn, Illinois, United States, 60453
United States, Louisiana
Investigational Site Number 840078
Hammond, Louisiana, United States, 70403
United States, Michigan
Investigational Site Number 840070
Rochester Hills, Michigan, United States, 48098
United States, Mississippi
Investigational Site Number 840060
Ocean Springs, Mississippi, United States, 39564
United States, Missouri
Investigational Site Number 840024
Mexico, Missouri, United States, 65265
United States, New York
Investigational Site Number 840051
Great Neck, New York, United States, 11021
Investigational Site Number 840071
Rochester, New York, United States, 14642
United States, North Carolina
Investigational Site Number 840089
Winston Salem, North Carolina, United States, 27157-1071
United States, Ohio
Investigational Site Number 840046
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Investigational Site Number 840045
Phoenixville, Pennsylvania, United States, 19460
United States, Texas
Investigational Site Number 840019
Pasadena,, Texas, United States, 77505
Investigational Site Number 840088
San Antonio, Texas, United States, 78229
Investigational Site Number 840038
Sugar Land, Texas, United States, 77479
United States, Virginia
Investigational Site Number 840068
Charlottesville,, Virginia, United States, 22908
United States, Washington
Investigational Site Number 840034
Seattle, Washington, United States, 98104-2499
United States, Wisconsin
Investigational Site Number 840064
Wauwatosa, Wisconsin, United States, 53226
Austria
Investigational Site Number 040003
Innsbruck, Austria, 6020
Canada
Investigational Site Number 124002
Vancouver, Canada, V6Z 2K5
France
Investigational Site Number 250003
Grenoble, France, 38043
Investigational Site Number 250006
Vandoeuvre Les Nancy, France, 54511
Germany
Investigational Site Number 276001
Berlin, Germany, 14163
Investigational Site Number 276005
Hamburg, Germany, 79106
Investigational Site Number 276007
Hamburg, Germany, 20246
Italy
Investigational Site Number 380003
Firenze, Italy, 50141
Investigational Site Number 380006
San Giovanni Rotondo, Italy, 71013
Poland
Investigational Site Number 616001
Gdynia, Poland, 81-969
Investigational Site Number 616005
Lodz, Poland, 90-302
Investigational Site Number 616002
Lodz, Poland, 90302
Investigational Site Number 616004
Lodz, Poland, 90-242
Investigational Site Number 616007
Poznan, Poland, 60539
Investigational Site Number 616006
Sroda Wielkopolska, Poland, 63-000
Investigational Site Number 616008
Warszawa, Poland, 03-580
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: August 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014