BioinvestGPT

BioinvestGPT ApS · Research use only

NCT06411379 (Sonelokimab in Moderate to Severe Hidradenitis Suppurativa): BVCT ex-ante prediction vs. reported outcome

On 26 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 28 Sep 2025 readout could not be adjudicated and sits outside the scored cohort.

Clinical Trial

NCTID
NCT06411379
Acronym
VELA-2
Drug Name
Sonelokimab
Drug MoA
trivalent nanobody that binds IL17A IL17F and serum albumin
Drug Modality
nanobody biologic
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Moderate to Severe Hidradenitis Suppurativa
Human Patients
418
Sponsor
MoonLake Immunotherapeutics
Phase
Phase 3

Prediction of , index 1993

Prospective Prediction
Prediction Index
1993
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in HiSCR75 slightly superior to bimekizumab and moderately superior to brivekimig)
Technical Prediction
SUCCESS (statistically significant clinical benefit in HiSCR75 compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
155 days in advance
Readout Data Interpretation
sonelokimab has achieved 10.3% placebo-adjusted HiSCR75 (p=0.033)
Press Release
Prediction Result
Prediction Accuracy
Unadjudicatable Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient; Unadjudicatable prediction due to ill-defined inclusion & exclusion criteria that fail to account for large inter-patient heterogeneity resulting in abnormally high placebo HiSCR75 (25.6% in VELA-2 vs 17.5% in VELA-1)
Prediction Classification
—

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Phase
Phase 3
Status
Completed
Enrollment
418
Lead sponsor
MoonLake Immunotherapeutics AG
Conditions
Hidradenitis Suppurativa
Interventions
DRUG: Sonelokimab; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2024-05-14
Primary completion
2025-08-14
Completion
2026-05-20
Primary outcomes
  • Hidradenitis Suppurativa Clinical Response 75 (Week 16)

NCT06411379 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials