To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
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
Key facts
- Study ID
- NCT05497284
- Run by
- Novartis Pharmaceuticals
- People needed
- 46
- Starts
- 2022-11-10
- Expected to finish
- 2024-09-26
- Last updated by the study team
- 2026-01-13
Who can join
Age: 40 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Clinical diagnosis of any connective tissue disease
- 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.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of Kansas Hospital — Kansas City, Kansas, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Ranelagh Partido de Berazate, Buenos Aires, Argentina
- Novartis Investigative Site — Paraná, Argentina
- Novartis Investigative Site — Camperdown, New South Wales, Australia
- Novartis Investigative Site — Chermside, Queensland, Australia
- Novartis Investigative Site — Spearwood, Western Australia, Australia
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Munich, Bavaria, Germany
- Novartis Investigative Site — Coswig, Germany
- Novartis Investigative Site — Essen, Germany
- Novartis Investigative Site — Amsterdam, North Holland, Netherlands
- Novartis Investigative Site — Nieuwegein, Utrecht, Netherlands
- Novartis Investigative Site — Bialystok, Poland
Full record on ClinicalTrials.gov
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