BioinvestGPT ApS · Research use only

NCT06162728 (Briquilimab in Chronic Spontaneous Urticaria): BVCT ex-ante prediction vs. reported outcome

On 31 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 8 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to both omalizumab an barzolvolimab).

Clinical Trial

Acronym
BEACON
Drug Name
Briquilimab
Drug MoA
anti-cKIT mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Chronic Spontaneous Urticaria
Human Patients
80
Sponsor
Jasper Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1711

Prospective Prediction
Prediction Index
1711
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in UAS7 inferior to barzolvolimab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in UAS7)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
161 days in advance
Readout Data Interpretation
briquilimab highest dose 180mg Q8W achieved 21% placebo-adjusted CR at week 12 vs. 31% placebo-adjusted CR at week 12 achieved by barzolvolimab highest dose in NCT05368285 vs 27% placebo-adjusted CR at week 12 achieved by omalizumab in ASTERIA I study (DOI-0.1038/jid.2014.306)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to both omalizumab an barzolvolimab)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines and/or Omalizumab, or Who Cannot Tolerate Omalizumab
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
87
Lead sponsor
Jasper Therapeutics, Inc.
Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG: Briquilimab; OTHER: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2023-11-29
Primary completion
2026-07-08
Completion
2026-07-08
Primary outcomes
  • Evaluate the safety and tolerability of briquilimab (From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 48 weeks))

NCT06162728 on ClinicalTrials.gov

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