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)

Who can take part?

You may be able to take part if you have idiopathic pulmonary fibrosis (IPF), a condition that causes scarring of the lungs, making it harder to breathe.

You may be eligible if you:

• Are 40 years of age or older
• Have a confirmed diagnosis of IPF based on a CT scan
• Meet certain lung function requirements based on breathing tests
• May or may not currently be taking medications such as nintedanib or pirfenidone

You would not be able to take part if:

• You have had certain serious medical conditions (such as cancer within the past few years or significant heart disease)
• You have significant emphysema
• You are pregnant or breastfeeding
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether axatilimab, an investigational medication, may help people with IPF.

Participants will be randomly assigned to receive either the study medication or a placebo.

• Study duration: Approximately 44 weeks
• Clinic visits: Regular visits every 2 weeks during treatment

The study includes:

• A screening period (8 weeks)
• A treatment period (26 weeks)
• A follow‑up period (10 weeks)

What will I need to do?

If you take part, you will be asked to:

• Receive the study medication as an intravenous infusion every 2 weeks
• Have blood tests before each treatment dose
• Attend clinic visits and study appointments
• Take part in assessments, which may include:
• • Blood tests
  • A heart tracing (ECG)
  • Breathing tests (spirometry)
  • Questionnaires about your health
  • Eye (ophthalmology) checks at the beginning and end of the study

You will also have regular contact with the study team throughout the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – Axatilimab Study