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

359 patients around the world

Available in Argentina, United States, Mexico, Chile

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.

AstraZeneca

359Patients around the world

This study is for people with

Pulmonary fibrosis

Idiopathic pulmonary fibrosis

Requirements for the patient

From 40 Years

All Gender

Medical requirements

: 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.

StudyARGiNAUT

SponsorAstraZeneca

Study typeInterventional

Conditions

Idiopathic pulmonary fibrosis

Requirements

From 40 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07652658