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NCT05695248 (STAR-0215 in Hereditary Angioedema): BVCT ex-ante prediction vs. reported outcome

On 21 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 25 Mar 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05695248
Acronym
ALPHA-STAR
Drug Name
STAR-0215
Drug MoA
YTE-modified anti-kallikrein mAb inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Hereditary Angioedema
Human Patients
28
Sponsor
Astria Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1397

Prospective Prediction
Prediction Index
1397
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with superior-to-lanadelumab efficacy and durability)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
95 days in advance
Readout Data Interpretation
-93% mean monthly HAE attacks vs -85% by PHVS’s deucrictibant; -92%-100% moderate to severe HAE attacks vs 83% by Takeda’s lanadelumab.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants With Hereditary Angioedema (The ALPHA-STAR Trial)
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
29
Lead sponsor
Astria Therapeutics, Inc.
Conditions
Hereditary Angioedema
Interventions
DRUG: Navenibart
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-02-21
Primary completion
2025-03-13
Completion
2025-03-13
Results first posted
2026-05-08
Primary outcomes
  • Number of Participants Experiencing Treatment-emergent Adverse Events (Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3))

NCT05695248 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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