| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02921971 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | PHASE2 | COMPLETED | 97 | — | — | Dec 21, 2016 | Apr 1, 2019 | Mar 21, 2022 | 44 | United States, Argentina +11 |
mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24. |
| SAR156597 | EXPERIMENTAL | SAR156597 200 milligram (mg), single SC injection QW up to Week 24. |
| Name | Type | Description |
|---|---|---|
| SAR156597 | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
Inclusion criteria : * Systemic Sclerosis (SSc) according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria. * Diffused cutaneous form of SSc according to Leroy's criteria. * Able and willing to sign the written informed consent form with compr...