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NCT06102005 (Lunsekimig in Asthma): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 7 Apr 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient.

Clinical Trial

NCTID
NCT06102005
Acronym
AIRCULES
Drug Name
Lunsekimig
Drug MoA
targeting IL-13 and TSLP
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Asthma
Human Patients
685
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1977

Prospective Prediction
Prediction Index
1977
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit to SoC in AAER/FEV1/ACQ5/ACQ7)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to SoC in AAER/FEV1/ACQ5/ACQ7 compared with placebo featuring positive severity-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
354 days in advance
Readout Data Interpretation
lunsekimig met its primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful reduction in exacerbations and improvement in lung function, as measured by pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1). efficacy observed regardless of baseline biomarker status; well tolerated.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma
Phase
Phase 2
Status
Completed
Enrollment
685
Lead sponsor
Sanofi
Conditions
Asthma
Interventions
DRUG: Lunsekimig; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-10-16
Primary completion
2026-02-23
Completion
2026-03-11
Primary outcomes
  • Annualized rate of asthma exacerbation events (From baseline to week 48)

NCT06102005 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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