Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

Change From Baseline in Forced Vital Capacity at Week 52

Timeframe: Baseline (Day 1) and Week 52

The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).

Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52

Timeframe: Baseline (Day 1) and Week 52

The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer. Background therapy included nintedanib or pirfenidone. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). Change from baseline in FVC was assessed for participants on background therapy and not on background therapy at Baseline.

Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Dyspnea and Cough Domain Scores at Week 52

Timeframe: Baseline (Day 1) and Week 52

The L-PF questionnaire was developed to assess symptoms and health-related quality of life in participants with IPF. Questionnaire consisted of 44 items divided into 2 modules: symptoms (23 items) and impacts (21 items). Dyspnea (shortness of breath) symptom domain consisted of 12 items, each item score ranged from 0 to 5 and cough symptom domain consisted of 6 items, each item score ranged from 0 to 4. Total score was calculated based on average of item ratings within each domain, multiplied by 100; ranged from 0 to 100 with higher scores indicated greater impairment of disease. Baseline: data collected prior to and closest to administration of first dose of study drug (bexotegrast or placebo). Change from Baseline in L-PF dyspnea and cough domain scores are presented here.

Number of Participants With an Event of Disease Progression

Timeframe: Baseline (Day 1) and up to Week 52

Number of participants with an event of disease progression was defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The ITT population included all randomized participants, regardless of study drug exposure.

Change From Baseline in Quantitative Lung Fibrosis (QLF) Extent at Week 52

Timeframe: Baseline (Day 1) and Week 52

High-resolution computerized tomography (HRCT) scans were conducted to assess the extent of QLF in the whole lung. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The CT protocol population included all participants in the ITT analysis set with evaluable HRCT imaging data per the following criteria: Baseline HRCT scans were \<35 days from randomization, Participant did not experience an exacerbation or progression of IPF AE within approximately 2 weeks prior to a HRCT scan, No identification of HRCT quality issues per the HRCT Imaging Charter.

Percentage of Participants With a ≥10% Absolute Decline in Forced Vital Capacity Percent Predicted From Baseline or All-cause Mortality Through Week 52

Timeframe: Baseline (Day 1) and up to Week 52

Percentage of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52 was planned. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The ITT population included all randomized participants, regardless of study drug exposure.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days

An AE was any event, side-effect, or other untoward medical occurrence that occurred in conjunction with the use of a study drug in humans, whether or not considered to have a causal relationship to the study drug. An SAE was any untoward medical occurrence, that any dose, was life-threatening, resulted in death, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or an important medical event. TEAEs were AEs that emerged or worsened in severity after the first administration of study drug and 14 days post last dose of study drug. The safety population included all participants who were randomized into the study and received at least 1 dose of study drug.

Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52

Timeframe: Baseline (Day 1) and Week 52

The K-BILD was a brief, self-completed health status measure of ILD which contained 15 items that measured health status in 3 domains (breathlessness and activities \[4 items\], chest symptoms \[3 items\], and psychological \[7 items\]) on a 7-point Likert scale ranging from 0 (severe symptoms) to 6 (no symptoms at all). The K-BILD domain and total score ranges were weighted and transformed; total score ranged from 0 to 100 with higher scores indicated best health status. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).

Number of Participants With Disease Progression for Hazard Ratio

Timeframe: Baseline (Day 1) and up to Week 52

Number of participants with disease progression (defined as adjudicated hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality) for hazard ratio. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The ITT population included all randomized participants, regardless of study drug exposure.