Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001369-34 | EudraCT Number | ||
| U1111-1127-2854 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.
Secondary Objectives:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR100842 | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR100842 | Drug | Pharmaceutical form: tablets Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 8 in biomarkers obtained from blood and skin | Day 1 and Week 8 (core part) | |
| Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS) | Day 1 and Week 8 (core part) |
Not provided
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840006 | Scottsdale | Arizona | 85259-5499 | United States | ||
| Investigational Site Number 840003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29732731 | Derived | Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6. |
Not provided
Not provided
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628738 | SAR-100842 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (for SAR100842) | Drug | Pharmaceutical form: tablets Route of administration: oral |
|
| Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score | Day 1 and Week 8 (core part) |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Investigational Site Number 840004 | Baltimore | Maryland | 21287 | United States |
| Investigational Site Number 840001 | Boston | Massachusetts | 02118 | United States |
| Investigational Site Number 840002 | Ann Arbor | Michigan | 48106 | United States |
| Investigational Site Number 840007 | New Brunswick | New Jersey | 08903 | United States |
| Investigational Site Number 840008 | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigational Site Number 250003 | Lille | 59037 | France |
| Investigational Site Number 250001 | Paris | 75679 | France |
| Investigational Site Number 380001 | Milan | 20122 | Italy |
| Investigational Site Number 756001 | Zurich | 8091 | Switzerland |
| Investigational Site Number 826001 | London | United Kingdom |
| Investigational Site Number 826002 | Salford | M6 8HD | United Kingdom |