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

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: SAR339658; Other: Placebo

• Registration Number: NCT01659138
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-07
• Primary Completion: 2014-06
• Disposition First Submitted: 2015-11-03
• Disposition First Submitted QC: 2015-11-03
• Disposition First Posted: 2015-12-01
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR339658	SAR339658	SAR339658 at Weeks 0, 2, 4, and 6
Placebo	Placebo	Placebo at Weeks 0, 2, 4, and 6

Primary Outcome Measures

Name	Time	Method
Proportion of Participants with Clinical Response by Mayo Score	At Week 8

Secondary Outcome Measures

Name	Time	Method
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
Number of Participants with adverse events	Up to Week 17

Trial Locations

Locations (41)

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

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