A Phase 2 trial of AGMB-447 in participants with idiopathic pulmonary fibrosis

Prior treatment

• Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
• Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
• History of lung volume reduction surgery or lung transplant or major surgery performed within 3 months prior to baseline or planned during the trial (being on a transplant list is allowed)
• Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.

Other illness

• Diagnosis of fibrosing interstitial lung disease (ILD) other than IPF.
• Systemic or opportunistic infections including: a. Active infection with human immunodeficiency virus. b. Known current tuberculosis infection. c. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). d. Chronic HCV (positive hepatitis C virus antibody [HCVAb] and hepatitis C virus [HCV] RNA).

• Participant aged ≥40 years at the time of signing the ICF.
• Diagnosis of IPF within 7 years prior to the screening visit, confirmed by centrally reviewed HRCT of the chest
• Confirmed pulmonary function criteria at screening, as follows: a. FVC ≥45% predicted of normal, as determined by spirometry, b. FEV1/FVC >0.7 or lower limit or normal, as determined by spirometry, c. DLCO corrected for hemoglobin ≥25% predicted of normal.
• On standard of care for the treatment of IPF, at a stable dose for at least 8 weeks before the screening visit, and during the screening period; or not on antifibrotic treatment and stable for at least 4 weeks before the screening visit (naïve or intolerant).
• Women of non childbearing potential or male participants willing to comply with this protocol's requirements regarding contraception.