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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06526377 | Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy | PHASE2 | NOT YET_RECRUITING | 150 | — | — | Sep 1, 2026 | Sep 1, 2028 | May 14, 2026 | - | — |
ASAS40 response is defined at least a 40% improvement in at least three of the four main ASAS domains, with no worsening in the remaining domain: Patient Global Assessment of Disease Activity (Q3 of ASDAS-CRP), Pain Assessment (BASDAI Q2), physical function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and Inflammation (represented by the mean of the two morning stiffness BASDAI questions Q5 and Q6).
| Arm | Type | Description |
|---|---|---|
| vilamakitug | EXPERIMENTAL | weekly dose of vilamakitug |
| placebo | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| vilamakitug | DRUG | Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human. |
| placebo | DRUG | placebo |
Inclusion Criteria: 1. Male or female aged ≥18 and ≤65 years, with body weight \>40 kg at screening, who are willing to provide informed consent, attend all clinic visits, comply with study-related procedures and able to understand and complete study-related questionnaires. 2. Must meet the ASAS-SP...