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NCT05368103 (daxdilimab in Alopecia Areata): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 7 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant (no placebo arm) and commercially insufficient.

Clinical Trial

NCTID
NCT05368103
Drug Name
daxdilimab
Drug MoA
anti-ILT7 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Alopecia Areata
Human Patients
30
Sponsor
Amgen
Phase
Phase 2

Prediction of , index 1449

Prospective Prediction
Prediction Index
1449
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
337 days in advance
Readout Data Interpretation
daxdilimab achieved 13.3% SALT20 response at week 24; which would be inferior to ritlecitinib that achieved 29.1% placebo-adjusted SALT20 response at week 24 (see the add'l link below); Further development has been discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant (no placebo arm) and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2A, Open Label, Proof of Concept Trial of Daxdilimab for the Treatment of Moderate To Severe Alopecia Areata
Phase
Phase 2
Status
Completed
Enrollment
30
Lead sponsor
Amgen
Conditions
Alopecia Areata
Interventions
BIOLOGICAL: Daxdilimab
Design
Single group · None
Primary purpose
Treatment
Start
2022-04-27
Primary completion
2023-08-07
Completion
2024-01-26
Results first posted
2025-01-07
Primary outcomes
  • Percent Change From Baseline in SALT Score at Week 24 (Baseline to Week 24)

NCT05368103 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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