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NCT06588738 (Envudeucitinib in Plaque Psoriasis): BVCT ex-ante prediction vs. reported outcome

On 8 Dec 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 6 Jan 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT06588738
Acronym
ONWARD2
Drug Name
Envudeucitinib (ESK-001)
Drug MoA
allosteric TYK2 inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Plaque Psoriasis
Human Patients
862
Sponsor
Alumis
Phase
Phase 3

Prediction of , index 2102

Prospective Prediction
Prediction Index
2102
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit in PASI75/PASI90 slightly-to-moderately superior to apremilast yet slightly-to-moderately inferior to bimekizumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in PASI75/PASI90 compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
29 days in advance
Readout Data Interpretation
Envudeucitinib achieved superior-to-apremilast 40% PASI100 at week 24 (p<0.0001), which is moderately inferior to 62% PASI100 at week 16 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 insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)
Phase
Phase 3
Status
Completed
Enrollment
862
Lead sponsor
Alumis Inc
Conditions
Plaque Psoriasis
Interventions
DRUG: Envudeucitinib; DRUG: Placebo; DRUG: Apremilast
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-08-20
Primary completion
2025-09-23
Completion
2025-12-18
Primary outcomes
  • To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo (16 weeks)

NCT06588738 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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