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New treatment option for Idiopathic Pulmonary Fibrosis (IPF)
Official title A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
ClinicalTrials.gov ID: NCT07652658
What this study is testing
What is AZD8965 low dose?
AZD8965 low dose is an investigational medicine, being studied as a potential treatment for idiopathic pulmonary fibrosis (ipf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- FVC ≥ 45% predicted of normal
- DLCO corrected for hemoglobin ≥ 25% predicted of normal
You likely can't join if
- ILD other than IPF
- The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
- Acute exacerbation of IPF
- Lower respiratory tract infection requiring treatment
- Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary...
- Heart failure
See the full eligibility criteria
- 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
- ILD other than IPF
- The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
- Acute exacerbation of IPF
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Ocala, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Champaign, Illinois, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
+ 150 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Loma Linda, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Sacramento, California, United States and 164 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.