Proof of biological activity of SAR100842 in Systemic Sclerosis

Conditions: Systemic Sclerosis
MedDRA version: 14.1Level: PTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-001369-34-IT

Lead Sponsor: SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and <36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score (mRSS) = 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies.Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening 2.Serum creatinine > 2.0 mg/dL 3. Gastrointestinal involvement preventing oral administration of study drug 4. Severe cardiac and/or pulmonary disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.;Secondary Objective: To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophoshatidic 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);Primary end point(s): Safety and tolerability during the 8 week treatment period (Number of patients reporting adverse events)</;Timepoint(s) of evaluation of this end point: Up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ)</;Timepoint(s) of evaluation of this end point: At Day 1 and 8 weeks