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NCT05415137 (Intravenous Efzofitimod in Pulmonary Sarcoidosis): BVCT ex-ante prediction vs. reported outcome

On 3 May 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 15 Sep 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT05415137
Acronym
EFZO-FIT
Drug Name
Intravenous Efzofitimod
Drug MoA
NRP2 agonist
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Sarcoidosis
Human Patients
268
Sponsor
aTyr Pharma
Phase
Phase 3

Prediction of , index 2000

Prospective Prediction
Prediction Index
2000
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate additive clinical benefit to OCS in FVC/KSQ-Lung slightly inferior to methotrexate +OCS)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to OCS in FVC/KSQ-Lung compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
135 days in advance
Readout Data Interpretation
Efzofitimod failed to achieve the primary endpoint of replacing OCS compared with placebo at week 48 (-2.57mg vs -3.52 mg; p=0.3313); moderately inferior to methotrexate whose efficacy in FVC achieved non-inferiority compared with OCS and thus could replace OCS (see add'l link below); Efzofitimod + OCS achieved 4.17 improvement in KSQ-Lung score at week 48 (10.36 vs 6.19; p=0.0479)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially significant and commercially maybe sufficient
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 Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
Phase
Phase 3
Status
Completed
Enrollment
268
Lead sponsor
aTyr Pharma, Inc.
Conditions
Pulmonary Sarcoidosis
Interventions
DRUG: Efzofitimod 3 mg/kg; DRUG: Efzofitimod 5 mg/kg; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-09-15
Primary completion
2025-06-25
Completion
2025-07-14
Primary outcomes
  • Change from baseline in mean daily oral corticosteroid (OCS) dose at Week 48 (Baseline to Week 48)

NCT05415137 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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