AZD8965 in IPF: see if three doses help IPF patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled study designed to compare three doses of AZD8965 with placebo over 24 weeks in about 360 adults with IPF. Participants may be on stable antifibrotic therapy or not receiving antifibrotic treatment. The trial will assess efficacy, safety, and tolerability, with results informing optimal dosing and tolerability in a diverse IPF population across ~200 sites globally. Eligible participants must have a diagnosis of IPF, adequate lung function, and no recent acute IPF events or major cardiovascular issues. Lead sponsor is AstraZeneca, with sites in Birmingham, AL and Phoenix, AZ.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 40 years
2. IPF diagnosis
3. Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care
4. FVC ≥ 45% predicted of normal
5. DLCO corrected for hemoglobin ≥ 25% predicted of normal

Exclusion Criteria:

1. ILD other than IPF
2. The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
3. Acute exacerbation of IPF
4. Lower respiratory tract infection requiring treatment
5. Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting
6. Heart failure
7. History of organ transplantation or is likely to receive lung transplantation

Where it's running

• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Newport Beach, California, United States Recruiting
• Research Site
  Denver, Colorado, United States Recruiting
• Research Site
  Atlanta, Georgia, United States Recruiting
• Research Site
  Boise, Idaho, United States Recruiting
• Research Site
  Champaign, Illinois, United States Recruiting

+148 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.