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NCT04204252 (inhaled AAT in Alpha 1-Antitrypsin Deficiency): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 8 Dec 2025 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
NCT04204252
Acronym
InnovAATe
Drug Name
inhaled AAT
Drug MoA
replacement Alpha 1-Antitrypsin
Drug Modality
protein
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases and Nutritional and Metabolic Diseases
Indication
Alpha 1-Antitrypsin Deficiency (AATD)
Human Patients
220
Sponsor
Kamada
Phase
Phase 3

Prediction of , index 2041

Prospective Prediction
Prediction Index
2041
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet weak clinical benefit in FEV1 slightly-to-moderately inferior to WVE006)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in FEV1 compared with placebo featuring a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
133 days in advance
Readout Data Interpretation
Inhaled AAT was deemed unlikely to demonstrate statistically significant benefit in FEV1 primary endpoint and was discontinued per DSMB futility analysis
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
Prospective Phase 3 Multi-center 2-Year Placebo Controlled Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 mg/Day in Alpha-1 Antitrypsin Deficiency With Moderate and Severe Airflow Limitation Followed by a 2-Year Open Label Extension
Phase
Phase 3
Status
Terminated
Enrollment
98
Lead sponsor
Kamada, Ltd.
Conditions
Alpha 1-Antitrypsin Deficiency
Interventions
DRUG: Alpha 1-Antitrypsin; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-11-25
Primary completion
2026-02-19
Completion
2026-02-27
Primary outcomes
  • FEV1 post bronchodilator (104 weeks)

NCT04204252 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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