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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02321709 | Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients | PHASE1 | COMPLETED | 21 | — | — | Nov 1, 2014 | Mar 1, 2016 | May 2, 2016 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| SAR113244 cohort 1 | EXPERIMENTAL | Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks) |
| SAR113244 cohort 2 | EXPERIMENTAL | Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks) |
| SAR113244 cohort 3 | EXPERIMENTAL | Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks) |
| Name | Type | Description |
|---|---|---|
| SAR113244 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
| placebo | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria: * Male or female patients, between 18 and 75 years of age, inclusive. * Clinical diagnosis of systemic lupus erythematosus (SLE) by American College Rheumatology criteria. * Autoantibody-posititve. * On active and stable SLE disease. Exclusion criteria: * Pregnant and nursing....