SNDX-6352 (Idiopathic Pulmonary Fibrosis)

A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

Study Population

Approximately 135 subjects are to be randomized, of whom 90 subjects are to receive axatilimab and 45 subjects are to receive placebo.

Eligible subjects must be:

≥40 years of age

have a diagnosis of IPF confirmed by HRCT (HRCT within 12 months)

have a FVC ≥45% predicted, DLCO 30-90% predicted

Subjects must be either: a) on nintedanib or pirfenidone for ≥12 weeks OR

b) not on nintedanib or pirfenidone

Subjects with a history of malignancy within previous 5 years, significant emphysema (>50% on HRCT), chronic heart failure or significant pulmonary hypertension, and women who are pregnant or lactating will not be eligible to participate in the study.

Study visits

Subjects will participate in the study for up to 44 weeks, inclusive of an 8-week Screening Period, a 26-week Treatment Period, and a 10-week Follow-up Period

Study Requirements

Subjects will receive study drug via intravenous infusion every 2 weeks for 24 weeks.

Blood test within 48 hours of infusion (results required prior to dosing)

Questionnaires, ECG, Blood tests, Spirometry at selected onsite vsits.

Ophthalmology review at start and end of study

Clinical Trials Registry:

https://clinicaltrials.gov/study/NCT06132256