← Back to all trials
Not Yet Recruiting
NCT07652658
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 359
Sponsor: AstraZeneca
Location: Research Site Birmingham Alabama
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07652658). StuddyBuddy aggregates publicly available trial information.