A Phase IIb Study to Evaluate AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Key facts
- Where
- Budapest Viii, Budapest XII, Debrecen és Törökbálint, MagyarországSee the 4 sites
- Phase
- 2. fázis
Where in Magyarország
- Clinic Of Pulmonology Semmelweis UniversityBudapest Viii, MagyarországTaking people
- Orszagos Koranyi Pulmonologiai IntezetBudapest XII, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Református Pulmonológiai CentrumTörökbálint, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2025-525016-41-00
- Record updated
- 2026. november 10.
- Original description
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24Read full original descriptionShow less
A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
Inclusion: Age ≥ 40 years; IPF diagnosis; Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care; FVC ≥ 45% predicted of normal; DLCO corrected for hemoglobin ≥ 25% predicted of normal.
Exclusion: Lower respiratory tract infection requiring treatment; Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting; Heart failure; History of organ transplantation or is likely to receive lung transplantation; ILD other than IPF; The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan; Acute exacerbation of IPF.