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NCT01651143 · ClinicalTrials.gov registry record · Phase 2

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

A Phase 2 study of Systemic Sclerosis, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target
13
Study locations

NCT01651143: Completed Phase 2 study of Systemic Sclerosis, sponsored by Sanofi.

NCT01651143 is a Phase 2 study of Systemic Sclerosis that has completed, run by Sanofi. The registered enrollment target is 32 participants, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (88% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01651143, a Phase 2 study of Systemic Sclerosis, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target
13
Study locations

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

Systemic Sclerosis

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

FieldValue
Enrollment Target 32 participants
Start Date 2013-01
Est. Completion 2014-04
Phase Phase 2
Sanofi

713 total trials

What the finished NCT01651143 record still lists

NCT01651143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (88% lower).

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.

NCT01651143 lists 13 locations in 8 states (Other, Arizona, District of Columbia).

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.

What interventions are being tested in trial NCT01651143?

The interventions under investigation include: SAR100842 (DRUG), Placebo (for SAR100842) (DRUG).

Who is sponsoring clinical trial NCT01651143?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Systemic Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01651143's enrollment target sits among peer trials

32 16th of 26 higher than 10 of 26 other Systemic Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Systemic Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01651143, the US trial registry maintained by the National Library of Medicine. NCT01651143 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.