Taking people in ItalyPhase 2
Testing AZD8965 Against Placebo in Adults With Idiopathic Pulmonary Fibrosis
Tests AZD8965 against placebo in adults with idiopathic pulmonary fibrosis.
Key facts
- Who runs it
- AstraZeneca AB
- Where
- Foggia, Forli', Modena, Monza, Pavia, Rozzano, Siena, and Turin, ItalySee the 8 sitesAlso in 9 other countries, 60 sites
- Trial code
- Registry title
- A Phase IIb Study to Evaluate AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 139 people, planned
- Started
- 4 Sept 2026
- Expected to end
- 18 Sept 2028
- Type of study
- Interventional
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF), whether or not they take approved antifibrotic medicine.
- Age
- 40 years or older
- Sex
- All sexes can join.
- Disease stage
- Idiopathic pulmonary fibrosis (IPF). Lung function: FVC at least 45% predicted of normal, and DLCO corrected for hemoglobin at least 25% predicted of normal.
- Earlier treatment
- People can be taking locally approved antifibrotic medicine at a stable dose, or not be taking standard treatment for IPF.
Main reasons for not taking part
- Lung disease other than IPF
- More emphysema than fibrotic change on the chest HRCT scan
- Sudden worsening (acute exacerbation) of IPF
- Lower airway infection that needs treatment
- Heart failure, a recent heart attack or unstable angina, or a past organ transplant
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 9 other countries, 60 sites
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaForli', ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Ospedaliero Universitaria SeneseSiena, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
About the trial
What the trial wants to find out
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)
- Plain-language title
- Testing AZD8965 Against Placebo in Adults With Idiopathic Pulmonary FibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 10 November 2026