Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Systemic Sclerosis
In brief
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.
Key facts
- Study ID
- NCT01651143
- Run by
- Sanofi
- People needed
- 32
- Starts
- 2013-01-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2016-03-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening
- Serum creatinine > 2.0 mg/dL
- Gastrointestinal involvement preventing oral administration of study drug
- Severe cardiac and/or pulmonary disease
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
- Investigational Site Number 840006 — Scottsdale, Arizona, United States
- Investigational Site Number 840003 — Washington D.C., District of Columbia, United States
- Investigational Site Number 840004 — Baltimore, Maryland, United States
- Investigational Site Number 840001 — Boston, Massachusetts, United States
- Investigational Site Number 840002 — Ann Arbor, Michigan, United States
- Investigational Site Number 840007 — New Brunswick, New Jersey, United States
- Investigational Site Number 840008 — Pittsburgh, Pennsylvania, United States
- Investigational Site Number 250003 — Lille, France
- Investigational Site Number 250001 — Paris, France
- Investigational Site Number 380001 — Milan, Italy
- Investigational Site Number 756001 — Zurich, Switzerland
- Investigational Site Number 826001 — London, United Kingdom
- Investigational Site Number 826002 — Salford, United Kingdom
Full record on ClinicalTrials.gov
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