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NCT06790121 (Lunsekimig in Atopic Dermatitis): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 7 Apr 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient (inferior to upadacitinib).

Clinical Trial

NCTID
NCT06790121
Acronym
VELVET
Drug Name
Lunsekimig
Drug MoA
targeting IL-13 and TSLP
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Atopic Dermatitis
Human Patients
150
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1978

Prospective Prediction
Prediction Index
1978
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit in EASI75/EASI90 slightly inferior to upadacitinib and moderately superior to dupilumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in EASI75/EASI90 compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
354 days in advance
Readout Data Interpretation
lunsekimig did not meet the primary endpoint of percent change from baseline in EASI score at week 24; improvements were seen in the key secondary endpoints measuring skin clearance including EASI75; generally well tolerated.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient (inferior to upadacitinib)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of 3 Subcutaneous Dose Regimens of Lunsekimig (SAR443765) in Adult Participants With Moderate-to-severe Atopic Dermatitis
Phase
Phase 2
Status
Completed
Enrollment
150
Lead sponsor
Sanofi
Conditions
Dermatitis Atopic
Interventions
DRUG: Lunsekimig; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2025-01-30
Primary completion
2026-02-12
Completion
2026-04-09
Primary outcomes
  • Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24 (From Baseline throughout the study, up to Week 24)

NCT06790121 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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