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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659138
Recruitment Status : Terminated (Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.)
First Posted : August 7, 2012
Last Update Posted : July 13, 2016
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: SAR339658 Other: Placebo Phase 2

Detailed Description:

The study period per patient will include up to 4 weeks screening, 8 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up 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, patients may be eligible to enter a long term safety study (LTS12593) for active treatment with SAR339658.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAR339658
SAR339658 at Weeks 0, 2, 4, and 6
Drug: SAR339658

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Other Name: Vatelizumab

Placebo Comparator: Placebo
Placebo at Weeks 0, 2, 4, and 6
Other: Placebo

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Primary Outcome Measures :
  1. Proportion of Participants with Clinical Response by Mayo Score [ Time Frame: At Week 8 ]

Secondary Outcome Measures :
  1. Proportion of Participants with Clinical Remission by Mayo Score [ Time Frame: At Week 8 ]
  2. Proportion of Participants with Mucosal Healing [ Time Frame: At Week 8 ]
  3. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: At Weeks 4 and 8 ]
  4. Change from Baseline in Quality of Life (QoL) SF-36 [ Time Frame: At Weeks 4 and 8 ]
  5. Change from Baseline in the partial Mayo Score [ Time Frame: At Weeks 4 and 6 ]
  6. Number of Participants with adverse events [ Time Frame: Up to Week 17 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659138

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Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi Identifier: NCT01659138    
Other Study ID Numbers: ACT12688
2012-002013-19 ( EudraCT Number )
U1111-1124-1076 ( Other Identifier: UTN )
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases