SAR100842

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Ensayo de Sanofi en Esclerosis sistemica.

Fase: Fase 2
Estado: Completado
Participantes: 32
Centros: 13
Fin del objetivo primario: nov 2013

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2013.

Qué mide

Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events (del registro, en inglés) (hasta 8 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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.

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Ficha completa en ClinicalTrials.gov (NCT01651143), actualizada en feb 2016.