Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01651143 | Proof of Biological Activity of SAR100842 in Systemic Sclerosis | PHASE2 | COMPLETED | 32 | — | — | Jan 1, 2013 | Apr 1, 2014 | Mar 25, 2016 | 13 | United States, France +3 |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| SAR100842 | DRUG | Pharmaceutical form: tablets Route of administration: oral |
| Placebo (for SAR100842) | DRUG | Pharmaceutical form: tablets Route of administration: oral |
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...