This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 participants will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
Participants will receive a daily oral dose of PIPE-791 in tablet form
Participants will receive a daily oral dose of PIPE-791 in tablet form
Participants will receive a daily oral dose of matching Placebo in tablet form
Absolute change in forced vital capacity (FVC) (mL)
Time frame: From baseline to Week 26
To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)
Time frame: From baseline to Week 30
Relative change in FVC (mL)
Additional assessment of disease progression through lung function measurements
Time frame: From baseline to Week 26
Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)
Time frame: From baseline to Weeks 12 and Week 26
Time to first ≥10% absolute decline in ppFVC
Time frame: From baseline to time of first ≥10% absolute decline, up to Week 26
Absolute change in ppFVC
Additional assessment of disease progression through lung function measurements
Time frame: From baseline to Week 26
Relative change in ppFVC
Additional assessment of disease progression through lung function measurements
Time frame: From baseline to Week 26
Change in quantitative CT-derived lung fibrosis burden on HRCT
Additional assessment of disease progression through imaging
Time frame: From baseline to Week 26
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