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SNDX-6352-0506 - Axatilimab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Axatilimab is a “monoclonal antibody”, which is an antibody manufactured in a laboratory. It is designed to specifically block a protein believed to be involved in lung fibrosis. By blocking this protein, Axatilimab may slow or stop the progression of IPF.

  • Category
  • Trial status
    Recruiting
  • Trial phase
    Phase 2 Drug Trial
    Early stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
  • Registry listing
  • ERM Project ID
    105552

Trial contact details

What you need to know

Who can take part?

  • Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society Clinical Practice Guideline (Raghu 2018).
  • Chest high-resolution computed tomography (HRCT) performed within 12 months prior to first Screening Visit 
  • FVC =45% of predicted normal at Screening Visits.
  • Forced expiratory volume in 1 second (FEV1)/FVC =0.7 at Screening Visits.
  • DLco =30% and =90% of predicted, corrected for hemoglobin at first Screening Visit.

Key exclusions:

  • Abnormalities detected on electrocardiogram (ECG) of either rhythm or conduction that in the opinion of the Investigator are clinical significant.
  • Emphysema present on =50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT.
  • Interstitial lung disease associated with known primary diseases 
  • Participants who cannot meet protocol-specified baseline stability criteria.
  • Acute IPF exacerbation within 3 months prior to screening.
  • Receiving nintedanib in combination with pirfenidone
  • Receiving systemic corticosteroids
  • History of cigarette smoking or vaping within the previous 3 months.
  • Female participant who is pregnant or breastfeeding.
  • Previous exposure to study intervention or known allergy/sensitivity to study drug.
  • Receiving an investigational treatment within 28 days of randomization.
  • Inadequate IV access.

What is involved for me?

The study drug will be given to you by intravenous (IV) infusion every 2 weeks for 26 weeks with the last dose administered at Week 24.

This research study will include 2 study treatment groups:

  • Axatilimab 0.3mg/kg; or
  • Placebo

As part of this research study, you will have blood samples taken to assess your health throughout your participation.

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