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.
This is a multicenter, randomized, double-blind, placebo-controlled and open-label active-controlled phase 3 clinical study conducted in China. This study plans to enroll 263 IPF participants. After completing screening assessments and meeting all enrollment criteria, IPF participants will be randomized in a 4:2:1 ratio to: AK3280 400 mg BID group (double-blind); Placebo BID group (double-blind); Pirfenidone 600 mg TID group (open-label). The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and record any adverse medical events. Participants are in the study for up to one and a half years. Subjects who complete the Week 52 visit of randomized controlled treatment study may be offered the opportunity to enter an open-label extension (OLE) study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Participants will receive AK3280 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.
Participants will receive placebo matching 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.
Participants will receive pirfenidone three times daily, within 30 minutes after meals. Initial dosing should be titrated gradually under doctor guidance: start with 200 mg each time, increase by 200 mg each time to maintain final dose of 600 mg each time within 2 weeks.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Absolute change from baseline in FVC at Week 52
The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
Time frame: Baseline to Week 52
Absolute change from baseline in FVC at Week 12, 24, and 42
The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
Time frame: Baseline to Week 12, 24, and 42
Proportion of participants with relative decline from baseline in FVC ≥10%, ≥15%, and ≥20% at Week 12, 24, 42, and 52
Relative decline from baseline in FVC ≥10%, ≥15%, and ≥20% indicates varying degrees of disease progression.
Time frame: At Week 12, 24, 42, and 52
Absolute change from baseline in standardized %pFVC at Week12, 24, 42, and 52
Standardized %pFVC is calculated as the ratio of measured FVC to predicted FVC. The predicted FVC is derived using a standardized formula.
Time frame: Baseline to Week 12, 24, 42, and 52
Proportion of participants with absolute decline from baseline in standardized %pFVC ≥10% at Week 12, 24, 42, and 52
Absolute decline from baseline in standardized %pFVC ≥10% indicates rapid disease progression.
Time frame: At Week 12, 24, 42, and 52
Absolute change from baseline in hemoglobin-corrected %pDLco at Week 12, 24, 42, and 52
The hemoglobin-corrected %pDLco measures the ability of oxygen moves from alveoli to blood.
Time frame: At Week 12, 24, 42, and 52
Change from baseline in L-PF score at Week 12, 24, 42, and 52
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The L-PF is a self-administered, quality of life questionnaire validated for patients with progressive fibrosing interstitial lung disease (ILD), including IPF.
Time frame: At Week 12, 24, 42, and 52
Change from baseline in 6MWT distance at Week 12, 24, 42, and 52
Time frame: At Week 12, 24, 42, and 52
Time to first acute exacerbation of IPF within 52 weeks
An exacerbation of IPF is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality in HRCT.
Time frame: Baseline to Week 52
Progression-free survival (PFS), defined as the time from randomization to disease progression or death, whichever occurs first.
IPF disease progression is defined as the occurrence of any of the following events: 1. ≥ 10% absolute decline from baseline in standardized %pFVC 2. ≥ 15% absolute decline from baseline in hemoglobin-corrected %pDLco 3. Unscheduled hospitalization due to respiratory events
Time frame: Baseline to Week 52
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 52 weeks
TEAEs and SAEs will be assessed via patient-reported symptoms, vital signs, physical examination, 12-lead ECG, HRCT, and laboratory assessments.
Time frame: Baseline to Week 52