To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Megadott ok: Sponsor Decision
Key facts
- Where
- CABA, Paraná és Ranelagh Partido de Berazate, ArgentínaSee the 3 sites
- Phase
- 2. fázis
Where in Argentína
- CABACABA, ArgentínaNo longer taking part
- ParanáParaná, ArgentínaNo longer taking part
- Ranelagh Partido de BerazateRanelagh Partido de Berazate, ArgentínaNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT05497284
- Record updated
- 2026. január 13.
- Original description
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosisRead full original descriptionShow less
A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
Inclusion: Male and female participants at least 40 years of age; IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines; FVC ≥45% predicted; DLCO, corrected for hemoglobin, ≥25% predicted (inclusive); Unlikely to undergo lung transplantation during this trial in the opinion of the investigator; If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization.
Exclusion: Clinical diagnosis of any connective tissue disease; Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening; Emphysema >20% on screening HRCT; Fibrosis <10% on screening HRCT; Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization; Additional protocol-defined inclusion / exclusion criteria may apply.