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
๐บ๐ธBoston, Massachusetts, United States
Investigational Site Number 250003
๐ซ๐ทLille, France
Investigational Site Number 840007
๐บ๐ธNew Brunswick, New Jersey, United States
Investigational Site Number 840004
๐บ๐ธBaltimore, Maryland, United States
Investigational Site Number 840006
๐บ๐ธScottsdale, Arizona, United States
Investigational Site Number 840003
๐บ๐ธWashington, District of Columbia, United States
Investigational Site Number 840008
๐บ๐ธPittsburgh, Pennsylvania, United States
Investigational Site Number 756001
๐จ๐ญZรผrich, Switzerland
Investigational Site Number 380001
๐ฎ๐นMilano, Italy
Investigational Site Number 250001
๐ซ๐ทParis Cedex 14, France
Investigational Site Number 826001
๐ฌ๐งLondon, United Kingdom
Investigational Site Number 826002
๐ฌ๐งSalford, United Kingdom
Investigational Site Number 840002
๐บ๐ธAnn Arbor, Michigan, United States