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NCT05767034 (Secukinumab in Polymyalgia Rheumatica): BVCT ex-ante prediction vs. reported outcome

On 2 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 Oct 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05767034
Acronym
REPLENISH
Drug Name
Secukinumab
Drug MoA
anti-IL17A inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Polymyalgia Rheumatica (PMR)
Human Patients
381
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3

Prediction of , index 1649

Prospective Prediction
Prediction Index
1649
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in sustained remission superior to tocilizumab in combination with 24wk prednisone taper regimen)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in sustained remission in combination with 24wk prednisone taper regimen; though secukinumab‘s additive efficacy for PMR would be smaller than that for GCA)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
477 days in advance
Readout Data Interpretation
Secukinumab + SoC met the primary endpoint and all secondary endpoints at week 52 compared with SoC alone
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
Phase
Phase 3
Status
Completed
Enrollment
381
Lead sponsor
Novartis Pharmaceuticals
Conditions
Polymyalgia Rheumatica
Interventions
DRUG: Secukinumab 300 mg; DRUG: Secukinumab 150 mg; OTHER: Placebo to secukinumab
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-03-22
Primary completion
2025-09-10
Completion
2026-02-16
Primary outcomes
  • Proportion of participants achieving sustained remission (at Week 52)

NCT05767034 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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