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

NCT01659138 | Terminated Phase 2 DMC

• 3 other identifiers: ACT126882012-002013-19U1111-1124-1076
• Study Type: interventional
• Target: 28
• Locations: 7 countries
• Sites: 41

Brief Summary

Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Clinical Response by Mayo Score

  At Week 8

Secondary Outcomes (6)

• Proportion of Participants with Clinical Remission by Mayo Score

  At Week 8

• Proportion of Participants with Mucosal Healing

  At Week 8

• Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

  At Weeks 4 and 8

• Change from Baseline in Quality of Life (QoL) SF-36

  At Weeks 4 and 8

• Change from Baseline in the partial Mayo Score

  At Weeks 4 and 6

Study Arms (2)

SAR339658

EXPERIMENTAL

SAR339658 at Weeks 0, 2, 4, and 6

Drug: SAR339658

Placebo

PLACEBO COMPARATOR

Placebo at Weeks 0, 2, 4, and 6

Other: Placebo

Interventions

SAR339658 DRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

Also known as: Vatelizumab

SAR339658

Placebo OTHER

Pharmaceutical form: solution for infusion Route of administration: intravenous

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (41)

Investigational Site Number 840065

Sun City, Arizona, 85351, United States

Location

Investigational Site Number 840059

Mission Hills, California, 91345, United States

Location

Investigational Site Number 840074

San Diego, California, 92114, United States

Location

Investigational Site Number 840061

Littleton, Colorado, 80120, United States

Location

Investigational Site Number 840003

Miami, Florida, 33136, United States

Location

Investigational Site Number 840008

Miramar, Florida, 33025, United States

Location

Investigational Site Number 840048

Winter Park, Florida, 32789, United States

Location

Investigational Site Number 840053

Savannah, Georgia, 31405, United States

Location

Investigational Site Number 840001

Chicago, Illinois, 60637, United States

Location

Investigational Site Number 840005

Oak Lawn, Illinois, 60453, United States

Location

Investigational Site Number 840078

Hammond, Louisiana, 70403, United States

Location

Investigational Site Number 840070

Rochester Hills, Michigan, 48098, United States

Location

Investigational Site Number 840060

Ocean Springs, Mississippi, 39564, United States

Location

Investigational Site Number 840024

Mexico, Missouri, 65265, United States

Location

Investigational Site Number 840051

Great Neck, New York, 11021, United States

Location

Investigational Site Number 840071

Rochester, New York, 14642, United States

Location

Investigational Site Number 840089

Winston-Salem, North Carolina, 27157-1071, United States

Location

Investigational Site Number 840046

Cincinnati, Ohio, 45219, United States

Location

Investigational Site Number 840045

Phoenixville, Pennsylvania, 19460, United States

Location

Investigational Site Number 840019

Pasadena, Texas, 77505, United States

Location

Investigational Site Number 840088

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 840038

Sugar Land, Texas, 77479, United States

Location

Investigational Site Number 840068

Charlottesville, Virginia, 22908, United States

Location

Investigational Site Number 840034

Seattle, Washington, 98104-2499, United States

Location

Investigational Site Number 840064

Wauwatosa, Wisconsin, 53226, United States

Location

Investigational Site Number 040003

Innsbruck, 6020, Austria

Location

Investigational Site Number 124002

Vancouver, V6Z 2K5, Canada

Location

Investigational Site Number 250003

Grenoble, 38043, France

Location

Investigational Site Number 250006

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number 276001

Berlin, 14163, Germany

Location

Investigational Site Number 276007

Hamburg, 20246, Germany

Location

Investigational Site Number 276005

Hamburg, 79106, Germany

Location

Investigational Site Number 380003

Florence, 50141, Italy

Location

Investigational Site Number 380006

San Giovanni Rotondo, 71013, Italy

Location

Investigational Site Number 616001

Gdynia, 81-969, Poland

Location

Investigational Site Number 616004

Lodz, 90-242, Poland

Location

Investigational Site Number 616005

Lodz, 90-302, Poland

Location

Investigational Site Number 616002

Lodz, 90302, Poland

Location

Investigational Site Number 616007

Poznan, 60539, Poland

Location

Investigational Site Number 616006

Środa Wielkopolska, 63-000, Poland

Location

Investigational Site Number 616008

Warsaw, 03-580, Poland

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 7, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: April 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (25); IT (2); CA (1); FR (2); PL (7); DE (3); AU (1)