FIBRONEER-ILD (nerandomilast low-dose)
Trial question
What is the role of nerandomilast in patients with progressive pulmonary fibrosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 785
785 patients (351 female, 434 male).
Inclusion criteria: patients with progressive pulmonary fibrosis.
Key exclusion criteria: other clinically significant pulmonary abnormalities; acute ILD exacerbation in the past 3 months; relevant chronic or acute infections, including HIV and viral hepatitis; ILD due to SARS-CoV-2 infection; major surgery performed within 6 weeks prior to visit 2 or planned during the trial period.
Interventions
N=393 nerandomilast (at a dose of 9 mg BID).
N=392 placebo (matching placebo BID).
Primary outcome
Mean decline in forced vital capacity at week 52
84.6 mL
165.8 mL
165.8 mL
124.4 mL
82.9 mL
41.5 mL
0.0 mL
Nerandomilast
Placebo
Significant
decrease ▼
Significant decrease in mean decline in FVC at week 52 (84.6 mL vs. 165.8 mL; MD -81.1, 95% CI -116.3 to -46).
Secondary outcomes
No significant difference in first acute exacerbation of ILD, hospitalization for a respiratory cause, or death (28% vs. 31.1%; HR 0.88, 95% CI 0.68 to 1.14).
Significant decrease in death (8.4% vs. 12.8%; HR 0.6, 95% CI 0.38 to 0.95).
No significant difference in hospitalization for respiratory cause or death (24.7% vs. 28.1%; HR 0.83, 95% CI 0.63 to 1.1).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with progressive pulmonary fibrosis, nerandomilast was superior to placebo with respect to mean decline in FVC at week 52.
Reference
Toby M Maher, Shervin Assassi, Arata Azuma et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 May 19. Online ahead of print.
Open reference URL