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
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Trial status
Recruiting
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Trial phase
Phase 2 Drug TrialEarly stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
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ERM Project ID
105552
Trial contact details
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Contact person
RIO Clinical Trials
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Phone
07 3163 1369
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.