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.
Inclusion Criteria:
Exclusion Criteria:
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During the main study phase, participants, care Provider, and investigators are blinded to AK3280 versus placebo allocation but not to pirfenidone; pulmonary function assessors are blinded to all three groups. The extension study is an open-label phase.
During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner.
During the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner.
During the randomized controlled treatment study, participants will receive pirfenidone titrated gradually to 600 mg three times daily in an open-label manner.