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A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.

NCT07652658

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Interventions: Placebo for AZD8965, AZD8965 low dose, AZD8965 medium dose, AZD8965 high dose

Countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, China, Denmark

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 overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (190)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, 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
  • Detroit, Michigan, United States
  • New York, New York, United States
  • New York, New York, United States
  • Greensboro, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Bethlehem, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • + 160 more on CT.gov