Proof of Biological Activity of SAR100842 in Systemic Sclerosis

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.

Timeline

Start

2013-01

Primary completion

2013-11

Completion

2014-04

Publications

• Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6.

Drugs

Indications