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NCT05934526 (Seralutinib in Pulmonary Arterial Hypertension): BVCT ex-ante prediction vs. reported outcome

On 14 Nov 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 Feb 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05934526
Acronym
PROSERA
Drug Name
Seralutinib
Drug MoA
inhaled PDGFR/CSF1R/c-KIT tyrosine kinase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Arterial Hypertension
Human Patients
390
Sponsor
Gossamer Bio
Phase
Phase 3

Prediction of , index 2087

Prospective Prediction
Prediction Index
2087
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to background therapies in 6MWD moderately inferior to inhaled treprostinil)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit to background therapies in 6MWD compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
101 days in advance
Readout Data Interpretation
seralutinib did not achieve statistically significant placebo-adjusted improvement in 6MWD at week 24; (p=0.0320, did not meet α=0.025 threshold)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant 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 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
Phase
Phase 3
Status
Completed
Enrollment
390
Lead sponsor
GB002, Inc.
Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG: Placebo; DRUG: Seralutinib; DEVICE: Generic Dry Powder Inhaler
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-12-28
Primary completion
2025-11-27
Completion
2025-12-22
Primary outcomes
  • Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24 (Baseline to 24 weeks)

NCT05934526 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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