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NCT05496465 (ARS-1 in Urticaria): BVCT ex-ante prediction vs. reported outcome

On 20 Nov 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 26 Feb 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak and commercially insufficient.

Clinical Trial

NCTID
NCT05496465
Drug Name
ARS-1
Drug MoA
epinephrine spray
Drug Modality
medical device
Drug Class
Best-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Urticaria
Human Patients
24
Sponsor
ARS Pharmaceuticals
Phase
Phase 2

Prediction of , index 1336

Prospective Prediction
Prediction Index
1336
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
98 days in advance
Readout Data Interpretation
primary endpoint met with p<0.05 that's not comparable with CDX0159 that achieved 40.6% placebo-adjusted CR.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Single-Dose, Randomized, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares
Phase
Phase 2
Status
Completed
Enrollment
21
Lead sponsor
ARS Pharmaceuticals, Inc.
Conditions
Urticaria
Interventions
DRUG: ARS-1
Design
Randomized · Crossover · None
Primary purpose
Treatment
Start
2022-07-28
Primary completion
2024-02-29
Completion
2024-02-29
Results first posted
2026-04-07
Primary outcomes
  • Effect of ARS-1 Versus Placebo Based on a Patient Reported Pruritus/Hive Score (UAS score at 120 (± 10 min) minutes after dosing.)

NCT05496465 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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