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

Ulcerative Colitis Clinical Trial

— FUSCIA  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01659138
• Other study ID #: ACT12688
• Secondary ID: 2012-002013-19U1
• Status: Terminated
• Phase: Phase 2
• First received: August 3, 2012
• Last updated: July 12, 2016
• Start date: August 2012
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: April 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• SAR339658
Pharmaceutical form:solution for infusion Route of administration: intravenous

Other:
• Placebo
Pharmaceutical form: solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Austria	Investigational Site Number 040003	Innsbruck
Canada	Investigational Site Number 124002	Vancouver
France	Investigational Site Number 250003	Grenoble
France	Investigational Site Number 250006	Vandoeuvre Les Nancy
Germany	Investigational Site Number 276001	Berlin
Germany	Investigational Site Number 276005	Hamburg
Germany	Investigational Site Number 276007	Hamburg
Italy	Investigational Site Number 380003	Firenze
Italy	Investigational Site Number 380006	San Giovanni Rotondo
Poland	Investigational Site Number 616001	Gdynia
Poland	Investigational Site Number 616002	Lodz
Poland	Investigational Site Number 616004	Lodz
Poland	Investigational Site Number 616005	Lodz
Poland	Investigational Site Number 616007	Poznan
Poland	Investigational Site Number 616006	Sroda Wielkopolska
Poland	Investigational Site Number 616008	Warszawa
United States	Investigational Site Number 840068	Charlottesville,	Virginia
United States	Investigational Site Number 840001	Chicago	Illinois
United States	Investigational Site Number 840046	Cincinnati	Ohio
United States	Investigational Site Number 840051	Great Neck	New York
United States	Investigational Site Number 840078	Hammond	Louisiana
United States	Investigational Site Number 840061	Littleton	Colorado
United States	Investigational Site Number 840024	Mexico	Missouri
United States	Investigational Site Number 840003	Miami	Florida
United States	Investigational Site Number 840008	Miramar,	Florida
United States	Investigational Site Number 840059	Mission Hills	California
United States	Investigational Site Number 840005	Oak Lawn	Illinois
United States	Investigational Site Number 840060	Ocean Springs	Mississippi
United States	Investigational Site Number 840019	Pasadena,	Texas
United States	Investigational Site Number 840045	Phoenixville	Pennsylvania
United States	Investigational Site Number 840071	Rochester	New York
United States	Investigational Site Number 840070	Rochester Hills	Michigan
United States	Investigational Site Number 840088	San Antonio	Texas
United States	Investigational Site Number 840074	San Diego	California
United States	Investigational Site Number 840053	Savannah,	Georgia
United States	Investigational Site Number 840034	Seattle	Washington
United States	Investigational Site Number 840038	Sugar Land	Texas
United States	Investigational Site Number 840065	Sun City	Arizona
United States	Investigational Site Number 840064	Wauwatosa	Wisconsin
United States	Investigational Site Number 840089	Winston Salem	North Carolina
United States	Investigational Site Number 840048	Winter Park,	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with Clinical Response by Mayo Score		At Week 8	No
Secondary	Proportion of Participants with Clinical Remission by Mayo Score		At Week 8	No
Secondary	Proportion of Participants with Mucosal Healing		At Week 8	No
Secondary	Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)		At Weeks 4 and 8	No
Secondary	Change from Baseline in Quality of Life (QoL) SF-36		At Weeks 4 and 8	No
Secondary	Change from Baseline in the partial Mayo Score		At Weeks 4 and 6	No
Secondary	Number of Participants with adverse events		Up to Week 17	Yes