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NCT04544293 (Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis): BVCT ex-ante prediction vs. reported outcome

On 1 Jan 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 26 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient clinical benefit.

Clinical Trial

NCTID
NCT04544293
Acronym
IMPALA-2
Drug Name
Molgramostim
Drug MoA
recombinant GM-CSF
Drug Modality
recombinant protein biologic
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Autoimmune Pulmonary Alveolar Proteinosis
Human Patients
160
Sponsor
Savara
Phase
Phase 3

Prediction of , index 1398

Prospective Prediction
Prediction Index
1398
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
177 days in advance
Readout Data Interpretation
lung function primary endpoint placebo-adjusted DLCO met at both 24 and 48 weeks (6 to 6.9 with p <0.001); yet 5/6 clinical benefit secondary endpoints (SRGQ total/activity scores and exercise capacity) not met at 24 weeks and 48 weeks with abnormal duration-response relationship.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet commercially insufficient clinical benefit
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Phase
Phase 3
Status
Active not recruiting
Enrollment
164
Lead sponsor
Savara Inc.
Conditions
Autoimmune Pulmonary Alveolar Proteinosis
Interventions
DRUG: Molgramostim; DRUG: Placebo; DRUG: Molgramostim Open-label
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-05-19
Primary completion
2023-11-30
Completion
2027-05-30
Results first posted
2025-08-07
Primary outcomes
  • Change From Baseline in Percent (%) Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted for Hemoglobin Concentration to Week 24 (From Baseline to Week 24)

NCT04544293 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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