A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)
AstraZeneca
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.
Description
This is a Phase IIb, randomized, placebo-controlled, double-blind, parallel-group 24-week study to assess the efficacy, safety and tolerability of three doses of AZD8965 versus placebo administered to participants with IPF. The enrolled participants will include those on stable dose(s) of one or two approved antifibrotic therapies and those who are not taking any antifibrotic therapy. Approximately 360 participants will be randomized across approximately 200 sites globally.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
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 ±…
Interventions
- OtherPlacebo for AZD8965
Placebo for AZD8965
- DrugAZD8965 low dose
AZD8965 low dose
- DrugAZD8965 medium dose
AZD8965 medium dose
- DrugAZD8965 high dose
AZD8965 high dose
Locations (190)
- Research SiteBirmingham, Alabama
- Research SitePhoenix, Arizona
- Research SitePhoenix, Arizona
- Research SiteLoma Linda, California
- Research SiteLos Angeles, California
- Research SiteNewport Beach, California