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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06245408 | A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State | PHASE3 | ACTIVE NOT_RECRUITING | 434 | — | — | Apr 8, 2024 | Dec 17, 2026 | Jan 8, 2026 | 194 | United States, Argentina +24 |
| Arm | Type | Description |
|---|---|---|
| Dazodalibep Dose 1 | EXPERIMENTAL | Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion. |
| Dazodalibep Dose 2 | EXPERIMENTAL | Participants will be administered dose 2 of dazodalibep by IV infusion. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo by IV infusion. |
| Name | Type | Description |
|---|---|---|
| Dazodalibep | DRUG | IV infusion |
| Placebo | DRUG | IV infusion |
Key Inclusion Criteria: 1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria 2. Have an ESSPRI score of ≥ 5 at screening. 3. Have an ESSDAI score of \< 5 at screening. 4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the stand...