Proof of Biological Activity of SAR100842 in Systemic Sclerosis
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ClinicalTrials.gov Identifier: NCT01651143 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : March 25, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Sclerosis | Drug: SAR100842 Drug: Placebo (for SAR100842) | Phase 2 |
Core part: randomized, double-blind, placebo-controlled study - 8-week treatment Extension part for participants completing the core part: Open label non-controlled study - 16-week treatment
Each patient's participation in the study will be approximately 13 or 33 weeks depending on their participation in the extension part: up to 2 weeks of screening, 8 weeks of treatment in the core part, 1 to 30 days wash-out between core part and extension part , 16 weeks of treatment in the extension part and 3 weeks of follow up.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: SAR100842
Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks |
Drug: SAR100842
Pharmaceutical form: tablets Route of administration: oral |
Placebo Comparator: Placebo
Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks |
Drug: SAR100842
Pharmaceutical form: tablets Route of administration: oral Drug: Placebo (for SAR100842) Pharmaceutical form: tablets Route of administration: oral |
- Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events [ Time Frame: Up to 8 weeks ]
- Change from baseline to Week 8 in biomarkers obtained from blood and skin [ Time Frame: Day 1 and Week 8 (core part) ]
- Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS) [ Time Frame: Day 1 and Week 8 (core part) ]
- Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score [ Time Frame: Day 1 and Week 8 (core part) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- 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.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651143
United States, Arizona | |
Investigational Site Number 840006 | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, District of Columbia | |
Investigational Site Number 840003 | |
Washington, District of Columbia, United States, 20007 | |
United States, Maryland | |
Investigational Site Number 840004 | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Investigational Site Number 840001 | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
Investigational Site Number 840002 | |
Ann Arbor, Michigan, United States, 48106 | |
United States, New Jersey | |
Investigational Site Number 840007 | |
New Brunswick, New Jersey, United States, 08903 | |
United States, Pennsylvania | |
Investigational Site Number 840008 | |
Pittsburgh, Pennsylvania, United States, 15213 | |
France | |
Investigational Site Number 250003 | |
Lille, France, 59037 | |
Investigational Site Number 250001 | |
Paris Cedex 14, France, 75679 | |
Italy | |
Investigational Site Number 380001 | |
Milano, Italy, 20122 | |
Switzerland | |
Investigational Site Number 756001 | |
Zürich, Switzerland, 8091 | |
United Kingdom | |
Investigational Site Number 826001 | |
London, United Kingdom | |
Investigational Site Number 826002 | |
Salford, United Kingdom, M6 8HD |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01651143 |
Other Study ID Numbers: |
ACT12339 2012-001369-34 ( EudraCT Number ) U1111-1127-2854 ( Other Identifier: UTN ) |
First Posted: | July 26, 2012 Key Record Dates |
Last Update Posted: | March 25, 2016 |
Last Verified: | February 2016 |
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis |
Pathologic Processes Connective Tissue Diseases Skin Diseases |