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NCT05162586 (enpatoran in systemic lupus erythematosus and cutaneous lupus…): BVCT ex-ante prediction vs. reported outcome

On 14 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 21 May 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
NCT05162586
Acronym
WILLOW
Drug Name
enpatoran (M5049)
Drug MoA
TLR7/8 dual inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
Human Patients
456
Sponsor
Merck KGaA
Phase
Phase 2

Prediction of , index 1617

Prospective Prediction
Prediction Index
1617
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in CLASI-A for CLE and BICLA for SLE)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in CLASI-A for CLE and BICLA for SLE)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
372 days in advance
Readout Data Interpretation
enpatoran has met the primary endpoint for both the CLE cohort (p=0.0002) and predefined subpopulations in the SLE cohort
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 Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)
Phase
Phase 2
Status
Completed
Enrollment
456
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Systemic Lupus Erythematosus
Interventions
DRUG: Enpatoran low dose; DRUG: Enpatoran medium dose; DRUG: Enpatoran high dose; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-03-31
Primary completion
2024-11-20
Completion
2024-11-20
Results first posted
2025-12-01
Primary outcomes
  • Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 (Baseline, week 16)
  • Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 (At Week 24)

NCT05162586 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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