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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04605978 | Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients | PHASE2 | COMPLETED | 48 | — | — | Aug 3, 2021 | May 9, 2023 | Apr 23, 2024 | 19 | United States, Australia +5 |
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
| Arm | Type | Description |
|---|---|---|
| S95011 concentrate for solution for infusion | EXPERIMENTAL | S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. |
| S95011 Placebo concentrate for solution for infusion | PLACEBO_COMPARATOR | S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| S95011 concentrate for solution for infusion | DRUG | IV administration every 2 weeks until week 4 and then every 3 weeks until week 10. |
| Placebo concentrate for solution for infusion | DRUG | IV administration every 2 weeks until week 4 and then every 3 weeks until week 10. |
Inclusion Criteria: 1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria 2. ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, he...