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NCT06411899 (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 is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (slightly superior to bimekizumab).

Clinical Trial

NCTID
NCT06411899
Acronym
VELA-1
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
422
Sponsor
MoonLake Immunotherapeutics
Phase
Phase 3

Prediction of , index 1992

Prospective Prediction
Prediction Index
1992
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 18.3% placebo-adjusted HiSCR75; slightly superior to 18% placebo-adjusted HiSCR75 achieved by bimekizumab (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (slightly superior to bimekizumab)
Prediction Classification
True Positive (TP)

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
422
Lead sponsor
MoonLake Immunotherapeutics AG
Conditions
Hidradenitis Suppurativa
Interventions
DRUG: Sonelokimab; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2024-05-15
Primary completion
2025-09-02
Completion
2026-05-14
Primary outcomes
  • Hidradenitis Suppurativa Clinical Response 75 (Week 16)

NCT06411899 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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