Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Status Completed

Clinical Trial 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).

Clinical Trial Description

Each patient's participation in the study will be approximately 13 weeks: up to 2 weeks of screening, 8 weeks of treatment and 3 weeks of follow up ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01651143
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 2
Start date	January 2013
Completion date	April 2014

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