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NCT06353971 (Briquilimab in Chronic Inducible 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 14 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (slightly inferior to barzolvolimab).

Clinical Trial

NCTID
NCT06353971
Acronym
SPOTLIGHT
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 Inducible Urticaria
Human Patients
27
Sponsor
Jasper Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1712

Prospective Prediction
Prediction Index
1712
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in provocation threshold inferior to barzolvolimab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in provocation threshold)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
318 days in advance
Readout Data Interpretation
briquilimab achieved 92% CR; which is slightly inferior to the 95% CR achieved by barzolvolimab (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (slightly inferior to 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 Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Phase
Phase 1, Phase 2
Status
Terminated
Enrollment
27
Lead sponsor
Jasper Therapeutics, Inc.
Conditions
Chronic Inducible Urticaria
Interventions
DRUG: Briquilimab
Design
Sequential · None
Primary purpose
Treatment
Start
2024-03-18
Primary completion
2025-07-31
Completion
2025-07-31
Primary outcomes
  • Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines. (From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36))

NCT06353971 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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