This is a phase 3 clinical study conducted in China. The primary objective is to compare the efficacy and safety of AK3280 400 mg versus placebo and active control (pirfenidone) in IPF patients.
Age ≥ 40 years at enrolment
Diagnosis of IPF per ATS/ERS/JRS/ALAT 2022 guidelines
HRCT central review completed during screening or within 12 months prior to screening. If participant did not undergo lung surgical biopsy, HRCT imaging must be consistent with usual interstitial pneumonia (UIP) pattern for definitive IPF diagnosis.
No prior anti-fibrotic treatment, or discontinued anti-fibrotic therapy for ≥4 weeks or 5 half-lives (whichever is longer) prior to randomization
History of hypersensitivity to pirfenidone or AK3280
Known intolerance to pirfenidone single dose of 200 mg (total daily dose 600 mg)
Hospitalization due to acute IPF exacerbation within 8 weeks prior to screening or during screening
Within 4 weeks prior to screening or during screening, local or systemic infection requiring: 1) Hospitalization ≥ 24 hours; or 2) Use of systemic antibiotics (IV, IM, oral, or inhaled)