Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tibulizumab · 1 trial · 2 indications
The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results
| Arm | Type | Description |
|---|---|---|
| Tibulizumab | EXPERIMENTAL | Subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Tibulizumab | BIOLOGICAL | Anti BAFF/IL-17 antibody |
| Placebo | OTHER | Placebo (inactive) |
Inclusion Criteria: * Male or female, 18 to 75 years of age * Body mass index between 18.0 and 38.0 kg/m² * Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria * Has diffuse cutaneous SSc, defined as mRSS \>0 over at least one skin area proximal to the elbows and/or knees,...
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