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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06843239 | Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) | PHASE2 | RECRUITING | 80 | — | — | Feb 6, 2025 | Jan 1, 2028 | Feb 12, 2026 | 51 | United States, Argentina +8 |
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,...