About The Study
Trial phase: IIb
Recruitment target: 135 participants
Duration: Up to 44 weeks
Study Locations
QLD
- Lung Research Queensland
What is involved?
This is a Phase 2b, randomized, double-blind, placebo- controlled, multi-center study to evaluate the efficacy, safety, and tolerability of axatilimab administered through Week 26 to subjects with IPF. Subjects meeting eligibility criteria for the study will be randomized in a 2:1 ratio to axatilimab 0.3 mg/kg every 2 weeks (Q2W) or placebo Q2W. Efficacy will be evaluated through pulmonary function tests (PFTs) including DLCO and patient-reported outcomes.
Investigational medicinal product, comparator and randomisation
- IMP: axatilimab
- Comparator: placebo
- Randomization: 2:1 axatilimab or placebo
Can I participate?
Inclusion Criteria
- Chest HRCT to confirm IPF criteria within 12 months of Screening Visit 1
- FVC ≥45% of predicted number during the Screening period
- FEV1/FVC ≥0.7 during the Screening Period.
- DLCO ≥30% and ≤90% during the Screening Period
Exclusion Criteria
- Emphysema present on ≥50% of the HRCT
- Interstitial lung disease associated with known primary disease
- Clinically significant ECG abnormalities
- Inability to meet protocol-specified baseline stability criteria
- Acute IPF exacerbation within 3 months prior to screening
- Receiving nintedanib in combination with pirfenidone
- Syndax Trial Summary SNDX-PACT-Trial-Summary.pdf
Further information or how to take part
If you would like to take part or have any questions about this research study, please fill out our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by Syndax Pharmaceuticals, Inc.
Clinicaltrials.gov ID: NCT06132256