Macrophage Targeting AXatilimab in Idiopathic Pulmonary FIbRosis (MAXPIRe) clinical trial
Macrophage Targeting AXatilimab in Idiopathic Pulmonary FIbRosis (MAXPIRe) clinical trial
Investigating axatilimab for the treatment of idiopathic pulmonary fibrosis (IPF).
This information is intended for potential clinical investigators and other interested healthcare professionals who may wish to enrol/refer patients to clinical trials.
MAXPIRe is sponsored by Syndax.
MAXPIRe study at a glance
Status: active – recruiting in locations outside the USA
Indication: IPF
ClinicalTrials.gov ID: NCT06132256
EudraCT number: 2022-502954-15-00
Syndax study code: SNDX-6352-0506
Sponsored by Syndax
Total duration of study: 44 weeks
Treatment duration: 26 weeks
Required study site visits: 10 to 18
Study drug: axatilimab or placebo
Mode of administration: IV infusion
Study phase: Phase IIb
Enrolment goal: 135 patients
Patient age: ≥40 years
Sex: Male and female
No history of smoking or vaping in the past 3 months
Neither pregnant nor breastfeeding
Female participants and males with childbearing partners must use effective contraceptive methods
MAXPIRe study objectives
The MAXPIRe study is an actively recruiting phase IIb clinical trial evaluating the efficacy, safety, and tolerability of axatilimab for the treatment of patients with IPF.
Primary study objective:
Assess lung function by measuring the change in FVC at 26 weeks
Secondary study objectives:
Time to disease progression
Assess additional lung function parameters, including:
– Change in FVC % predicted over 26 weeks
– Mean change in DLco
Assess QoL by measuring change in SGRQ score
Investigational axatilimab in the treatment of IPF
IPF is a chronic lung disease characterized by fibrosis, inflammation and destruction of lung architecture.1 CSF-1R is highly expressed during IPF pathogenesis and promotes key characteristics of profibrotic macrophage activity.2,3
Axatilimab is a monoclonal antibody administered by IV infusion, which inhibits CSF-1R, blocking the differentiation and function of profibrotic macrophages.3 By targeting a specific inflammatory cell, axatilimab works upstream of existing anti-fibrotics.1,3,4
This global axatilimab clinical trial for patients with IPF is investigational (not approved for IPF by any regulatory body). Axatilimab is approved for a different indication by the US FDA.5
MAXPIRe
study design
Eligibility criteria
Key inclusion criteria:
Male and female adults aged ≥40 years with a life expectancy of ≥12 months for non-IPF–related disease
Documented IPF diagnosis
HRCT meeting IPF criteria within 12 months of screening visit 1
– If HRCT is unavailable within 12 months of screening, it can be done at first visit
– If the patient has UIP and the HRCT was done >6 months ago, an additional HRCT scan may be required
FVC ≥45% of predicted normal
FEV1/FVC ratio ≥0.7
DLco ≥30% and ≤90% of predicted normal
Female participants and males with childbearing partners must use effective contraceptive methods
Key exclusion criteria:
History of smoking or vaping within the previous 3 months
Pregnant or breastfeeding
Emphysema on ≥50% of HRCT
Clinically significant ECG abnormalities
ILD associated with known primary disease
Acute IPF exacerbation within 3 months before screening
Receiving another investigational treatment within 28 days of randomisation
Use of any of the following within 4 weeks prior to screening, during screening, or planned during the study: imatinib, ambrisentan, azathioprine, mycophenolate mofetil cyclophosphamide, cyclosporine A, tacrolimus, bosentan, methotrexate, inhaled treprostinil, phosphodiesterase-5 inhibitors, including sildenafil (unless for occasional use), prednisone at a steady dose of >10 mg/day or equivalent, or other investigational therapy
Prednisone equivalent therapy equal to >10 mg/day within 2 weeks of screening
Receiving nintedanib in combination with pirfenidone
Inability to meet FVC baseline stability criteria
Inadequate IV access
Countries with active study sites
Australia
Belgium
Canada
Czech Republic
France
Germany
Italy
Poland
South Korea
Spain
Taiwan
United Kingdom
New Zealand (to become active shortly)
Abbreviations
CSF-1R, colony stimulating factor-1 receptor; DLco, diffusing capacity of the lungs for carbon monoxide; ECG, electrocardiogram; EudraCT, European Union Drug Regulating Authorities Clinical Trials Database; FDA, Food and Drug Administration; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; HRCT, high-resolution computed tomography; ILD, interstitial lung disease; IPF, idiopathic pulmonary fibrosis; IV, intravenous; MAXPIRe, Macrophage Targeting Axatilimab in Idiopathic Pulmonary Fibrosis; Q2W, once every 2 weeks; QoL, quality of life; SGRQ, St George’s Respiratory Questionnaire; UIP, usual interstitial pneumonia.
References
1. Glass DS, Grossfeld D, Renna HA, et al. Idiopathic pulmonary fibrosis: current and future treatment. Clin Respir J. 2022;16:84–96. doi:10.1111/CRJ.13466 2. Michalaki C, Maher TM, Lloyd CM, Molyneaux PL, Ordentlich P, Byrne AJ. Altered expression of CSF1R in airway macrophages during idiopathic pulmonary fibrosis. Eur Respir J. 2024;64(suppl 68):Abstract PA3382. doi:10.1183/13993003.CONGRESS-2024.PA3382 3. Kitko CL, Arora M, Defilipp Z, et al. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study. Journal of Clinical Oncology. 2022;41(10):1864. doi:10.1200/JCO.22.00958 4. Xu Y, Lan P, Wang T. The Role of Immune Cells in the Pathogenesis of Idiopathic Pulmonary Fibrosis. Medicina (B Aires). 2023;59(11):1984. doi:10.3390/MEDICINA59111984 5. FDA approves axatilimab-csfr | FDA. Accessed January 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axatilimab-csfr-chronic-graft-versus-host-disease
This information is intended for potential clinical investigators and other interested healthcare professionals who may wish to enrol/refer patients to clinical trials.
MAXPIRe is sponsored by Syndax.