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Proof of Biological Activity of SAR100842 in Systemic Sclerosis
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Systemic Sclerosis | Drug: SAR100842 Drug: Placebo (for SAR100842) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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) ]
| Enrollment: | 32 |
| Study Start Date: | January 2013 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Pharmaceutical form: tablets Route of administration: oral |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01651143 History of Changes |
| Other Study ID Numbers: |
ACT12339 2012-001369-34 ( EudraCT Number ) U1111-1127-2854 ( Other Identifier: UTN ) |
| Study First Received: | July 24, 2012 |
| Last Updated: | February 26, 2016 |
Additional relevant MeSH terms:
|
Sclerosis Scleroderma, Systemic Scleroderma, Diffuse |
Pathologic Processes Connective Tissue Diseases Skin Diseases |
ClinicalTrials.gov processed this record on August 18, 2017