Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
NCT01651143 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG SAR100842
- DRUG Placebo (for SAR100842)
Study Locations (13)
Other
- Investigational Site Number 250003 — Lille
- Investigational Site Number 250001 — Paris
- Investigational Site Number 380001 — Milan
- Investigational Site Number 756001 — Zurich
- Investigational Site Number 826001 — London
- Investigational Site Number 826002 — Salford
Arizona
- Investigational Site Number 840006 — Scottsdale
District of Columbia
- Investigational Site Number 840003 — Washington D.C.
Maryland
- Investigational Site Number 840004 — Baltimore
Massachusetts
- Investigational Site Number 840001 — Boston
Michigan
- Investigational Site Number 840002 — Ann Arbor
New Jersey
- Investigational Site Number 840007 — New Brunswick
Pennsylvania
- Investigational Site Number 840008 — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01651143
The ClinicalTrials.gov registry entry for NCT01651143 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Systemic Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which SAR100842 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01651143 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Other, Arizona, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01651143 about?
NCT01651143 is a clinical study titled "Proof of Biological Activity of SAR100842 in Systemic Sclerosis". 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 relate...
What is the current status of trial NCT01651143?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2013-01. Estimated completion is 2014-04.
What conditions does trial NCT01651143 study?
This clinical trial studies the following conditions: Systemic Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01651143?
The interventions under investigation include: SAR100842 (DRUG), Placebo (for SAR100842) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01651143?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01651143 being conducted?
This trial has 13 study locations across Arizona, District of Columbia, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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