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

NCT ID: NCT01659138

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-04-30

Brief Summary

Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAR339658

SAR339658 at Weeks 0, 2, 4, and 6

Group Type: EXPERIMENTAL

SAR339658

Intervention Type: DRUG

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Placebo

Placebo at Weeks 0, 2, 4, and 6

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Interventions

SAR339658

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

Placebo

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: OTHER

Other Intervention Names

Vatelizumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840065

Sun City, Arizona, United States

Investigational Site Number 840059

Mission Hills, California, United States

Investigational Site Number 840074

San Diego, California, United States

Investigational Site Number 840061

Littleton, Colorado, United States

Investigational Site Number 840003

Miami, Florida, United States

Investigational Site Number 840008

Miramar, Florida, United States

Investigational Site Number 840048

Winter Park, Florida, United States

Investigational Site Number 840053

Savannah, Georgia, United States

Investigational Site Number 840001

Chicago, Illinois, United States

Investigational Site Number 840005

Oak Lawn, Illinois, United States

Investigational Site Number 840078

Hammond, Louisiana, United States

Investigational Site Number 840070

Rochester Hills, Michigan, United States

Investigational Site Number 840060

Ocean Springs, Mississippi, United States

Investigational Site Number 840024

Mexico, Missouri, United States

Investigational Site Number 840051

Great Neck, New York, United States

Investigational Site Number 840071

Rochester, New York, United States

Investigational Site Number 840089

Winston-Salem, North Carolina, United States

Investigational Site Number 840046

Cincinnati, Ohio, United States

Investigational Site Number 840045

Phoenixville, Pennsylvania, United States

Investigational Site Number 840019

Pasadena, Texas, United States

Investigational Site Number 840088

San Antonio, Texas, United States

Investigational Site Number 840038

Sugar Land, Texas, United States

Investigational Site Number 840068

Charlottesville, Virginia, United States

Investigational Site Number 840034

Seattle, Washington, United States

Investigational Site Number 840064

Wauwatosa, Wisconsin, United States

Investigational Site Number 040003

Innsbruck, , Austria

Investigational Site Number 124002

Vancouver, , Canada

Investigational Site Number 250003

Grenoble, , France

Investigational Site Number 250006

Vandœuvre-lès-Nancy, , France

Investigational Site Number 276001

Berlin, , Germany

Investigational Site Number 276007

Hamburg, , Germany

Investigational Site Number 276005

Hamburg, , Germany

Investigational Site Number 380003

Florence, , Italy

Investigational Site Number 380006

San Giovanni Rotondo, , Italy

Investigational Site Number 616001

Gdynia, , Poland

Investigational Site Number 616004

Lodz, , Poland

Investigational Site Number 616005

Lodz, , Poland

Investigational Site Number 616002

Lodz, , Poland

Investigational Site Number 616007

Poznan, , Poland

Investigational Site Number 616006

Środa Wielkopolska, , Poland

Investigational Site Number 616008

Warsaw, , Poland

Countries

United States; Austria; Canada; France; Germany; Italy; Poland

Other Identifiers

2012-002013-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1124-1076

Identifier Type: OTHER

Identifier Source: secondary_id

ACT12688

Identifier Type: -

Identifier Source: org_study_id