Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telitacicept · 2 trials · 2 indications
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale is scored on a 0 to 3 (0=normal, 3=severe disease) point scale. The total score is the sum of all individual item scores ranging from 0 to 24. Higher scores indicate more severe disability due to MG. A decrease from Baseline score indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Telitacicept | EXPERIMENTAL | Telitacicept |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Telitacicept | BIOLOGICAL | Subcutaneous injection |
| Placebo | DRUG | Subcutaneous injection |
Inclusion Criteria: 1. Male or female aged 18 to 75 years of age (both inclusive) at screening 2. Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening. 3. ESSDAI ≥5 at screening (score calculated...