Proof of Biological Activity of SAR100842 in Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- Drug: Placebo (for SAR100842)
- Registration Number
- NCT01651143
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.
Secondary Objectives:
* To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin;
* To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS);
* To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ);
* To document long term safety of SAR100842 during the extension part.
- Detailed Description
Core part: randomized, double-blind, placebo-controlled study - 8-week treatment Extension part for participants completing the core part: Open label non-controlled study - 16-week treatment
Each patient's participation in the study will be approximately 13 or 33 weeks depending on their participation in the extension part: up to 2 weeks of screening, 8 weeks of treatment in the core part, 1 to 30 days wash-out between core part and extension part , 16 weeks of treatment in the extension part and 3 weeks of follow up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR100842 SAR100842 Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks Placebo SAR100842 Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks Placebo Placebo (for SAR100842) Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks
- Primary Outcome Measures
Name Time Method Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events Up to 8 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline to Week 8 in biomarkers obtained from blood and skin Day 1 and Week 8 (core part) Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS) Day 1 and Week 8 (core part) Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score Day 1 and Week 8 (core part)
Trial Locations
- Locations (13)
Investigational Site Number 840001
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 250003
🇫🇷Lille, France
Investigational Site Number 840007
🇺🇸New Brunswick, New Jersey, United States
Investigational Site Number 840004
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840006
🇺🇸Scottsdale, Arizona, United States
Investigational Site Number 840003
🇺🇸Washington, District of Columbia, United States
Investigational Site Number 840008
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 756001
🇨🇭Zürich, Switzerland
Investigational Site Number 380001
🇮🇹Milano, Italy
Investigational Site Number 250001
🇫🇷Paris Cedex 14, France
Investigational Site Number 826001
🇬🇧London, United Kingdom
Investigational Site Number 826002
🇬🇧Salford, United Kingdom
Investigational Site Number 840002
🇺🇸Ann Arbor, Michigan, United States