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NCT04294667 (Dapirolizumab Pegol in Systemic Lupus Erythematosus): BVCT ex-ante prediction vs. reported outcome

On 26 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 19 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (in BICLA at week 24) and commercially insufficient.

Clinical Trial

NCTID
NCT04294667
Acronym
PHOENYCS GO
Drug Name
Dapirolizumab Pegol
Drug MoA
anti-CD40L PEGylated fab
Drug Modality
fab biologic
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Systemic Lupus Erythematosus (SLE)
Human Patients
321
Sponsor
UCB SA
Phase
Phase 3

Prediction of , index 1562

Prospective Prediction
Prediction Index
1562
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
207 days in advance
Readout Data Interpretation
dapirolizumab achieved 14.9% placebo-adjusted BICLA at week 48 as an add-on the SoC (p=0.011) yet the key secondary endpoint BICLA at week 24 not met (usually BICLA at week 24 is the primary efficacy endpoint).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (in BICLA at week 24) 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-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Phase
Phase 3
Status
Completed
Enrollment
321
Lead sponsor
UCB Biopharma SRL
Conditions
Systemic Lupus Erythematosus
Interventions
DRUG: DZP; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-08-12
Primary completion
2024-05-22
Completion
2024-06-04
Results first posted
2025-04-24
Primary outcomes
  • Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 (Week 48)

NCT04294667 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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