Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.