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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 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.

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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

Sponsor

Sanofi

713 total trials

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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, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (88% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.