BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05856448 (GLPG3667 in Systemic Lupus Erythematosus): BVCT ex-ante prediction vs. reported outcome

On 17 Nov 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 18 Dec 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05856448
Acronym
GALACELA
Drug Name
GLPG3667
Drug MoA
selective TYK2 inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Systemic Lupus Erythematosus
Human Patients
186
Sponsor
Galapagos
Phase
Phase 2

Prediction of , index 2096

Prospective Prediction
Prediction Index
2096
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in SRI4/BICLA slightly superior to deucravacitinib)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in SRI4/BICLA compared with placebo featuring a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
31 days in advance
Readout Data Interpretation
GLPG3667 did not achieve statistically significant improvement in placebo-adjusted SRI4 at week 32
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal model of the effective GLPG3667 dosing despite correct modeling of negative dose-response relationship that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GLPG3667 in Adult Subjects With Active Systemic Lupus Erythematosus
Phase
Phase 2
Status
Completed
Enrollment
186
Lead sponsor
Lakefront Biotherapeutics NV
Conditions
Systemic Lupus Erythematosus
Interventions
DRUG: GLPG3667; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2023-06-28
Primary completion
2025-10-08
Completion
2026-02-27
Primary outcomes
  • Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32 (Week 32)

NCT05856448 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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