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周日报道，MoonLake三期VELA试验显示Sonelokimab在中度至重度增生性皮炎中取得了统计学显着的HiCR 75缓解
2025-09-29 14:35
- VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16
- Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treatment policy strategy to test the robustness of the results: difference between the two methods relates to the statistical handling of intercurrent events
- In the combined VELA program, patients treated with sonelokimab experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001)
- In VELA-1, sonelokimab achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001)
- In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053)
- The pre-specified treatment policy strategy provides for the analysis of data irrespective of intercurrent events; using this analysis, a statistically significant HiSCR75 at week 16 in VELA-1 and VELA-2 was achieved with sonelokimab (35% and 36%, respectively) vs placebo (18% and 26%, respectively); clinically meaningful and statistically significant benefit was also observed for all key secondary endpoints (Table 2)
- Sonelokimab continued to show a favourable safety profile with no new safety signals detected, including an absence of key events of interest such as suicidal ideation and behavior
- VELA progresses to its pre-specified week 52 readout and the Company will now seek to confirm the path to registration in HS with the appropriate regulatory authorities
- Other clinical studies with sonelokimab, including the Phase 3 VELA-TEEN trial in adolescent HS, the Phase 3 IZAR program and the Phase 2 P-OLARIS trial in psoriatic arthritis (PsA), the Phase 2 LEDA trial in palmoplantar pustulosis (PPP), and the Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA), continue as planned and are expected to support a catalyst-rich roadmap
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