Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: SAR339658

• Registration Number: NCT01861249
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

Detailed Description

The study period per patient will include 62 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.

Study Timeline

• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Study Start: 2013-07
• Primary Completion: 2014-05
• 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: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR339658	SAR339658	SAR339658, every 2 weeks (Q2W) or every 4 weeks (Q4W) according to clinical response at Week 8 in the ACT12688 trial

Primary Outcome Measures

Name	Time	Method
Percentage of participants with Adverse Events	Up to Week 68

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with abnormal safety parameters (laboratory data and vital signs)	Up to Week 68
Proportion of participants with Clinical Remission by Mayo Score	At Week 62
Proportion of participants with Mucosal Healing	At Week 62
Change from baseline in the partial Mayo Score	At Weeks 10, 22, 34, 46 and 58
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)	At Weeks 34 and 62

Trial Locations

Locations (5)

Investigational Site Number 840008; 🇺🇸 Miramar,, Florida, United States

Investigational Site Number 840048; 🇺🇸 Winter Park, Florida, United States

Investigational Site Number 840088; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 840059; 🇺🇸 Mission Hills, California, United States

Investigational Site Number 840024; 🇺🇸 Mexico, Missouri, United States