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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05349214 | Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome | PHASE3 | ACTIVE NOT_RECRUITING | 506 | — | — | Aug 4, 2022 | Apr 17, 2027 | Jun 3, 2026 | 146 | United States, Argentina +24 |
| NCT05350072 | Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome | PHASE3 | ACTIVE NOT_RECRUITING | 275 | — | — | Jul 28, 2022 | Jun 2, 2026 | May 14, 2026 | 77 | United States, Austria +16 |
* Plan A - United States of America and US reference countries * Plan B - EU, China, other non-US Regions and EU reference countries Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.
Efficacy (Plan A: US and US reference countries and Plan B: EU, China, other non-US Regions and EU reference countries) Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | ianalumab exposure level 1 |
| Arm B | EXPERIMENTAL | ianalumab exposure level 2 |
| Arm C | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| VAY736 | BIOLOGICAL | ianalumab s.c. |
| Placebo | OTHER | placebo s.c. |
Inclusion criteria * Signed informed consent must be obtained prior to participation in the study * Women and men ≥ 18 years of age * Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria * Time since diagnosis of Sjögren's of ≤ 7.5 years at screening * Positive anti-Ro/SSA ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | VAY736, Ianalumab, VAY736 PFS, VAY736 AI |
| Amgen Inc. | AMGN | 3 | PHASE3 | Dazodalibep |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Deucravacitinib |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE3 | Efgartigimod PH20 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| Vor Biopharma, Inc. | VOR | 1 | PHASE3 | Telitacicept |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Artiva Biotherapeutics, Inc. | ARTV | 1 | PHASE2 | Allogeneic NK Cells |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
| Precision BioSciences, Inc. | DTIL | 1 | PHASE1 | CD19 targeted CAR-T cells |