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Evaluating axatilimab for treating 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)

PHASE2 · Syndax Pharmaceuticals · NCT06132256

This study is testing a new treatment called axatilimab to see if it can help people with idiopathic pulmonary fibrosis breathe better and improve their health.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment135 (estimated)
Ages40 Years and up
SexAll
SponsorSyndax Pharmaceuticals (industry)
Drugs / interventionsimatinib, radiation, methotrexate, cyclophosphamide, prednisone, axatilimab
Locations72 sites (Camperdown, New South Wales and 71 other locations)
Trial IDNCT06132256 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of axatilimab, a novel treatment, in patients diagnosed with idiopathic pulmonary fibrosis (IPF). Participants will be randomly assigned to receive either axatilimab or a placebo, with their health monitored throughout the trial. The study follows strict eligibility criteria, including documented diagnosis and imaging requirements to ensure appropriate patient selection. The goal is to determine if axatilimab can improve outcomes for those suffering from this progressive lung disease.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a documented diagnosis of idiopathic pulmonary fibrosis as per established clinical guidelines.

Not a fit: Patients without a confirmed diagnosis of idiopathic pulmonary fibrosis or those who do not meet the specific imaging criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with idiopathic pulmonary fibrosis, potentially improving their quality of life and disease management.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in targeting IPF, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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 and according to the minimum requirements for IPF diagnosis by central review based on participant's HRCT only (if no lung biopsy is available) or based on both HRCT and lung biopsy (with application of the different criteria in either situation). If an evaluable HRCT \<12 months prior to Screening is not available, an HRCT can be performed at first Screening Visit to determine eligibility, according to the same requirements as the historical HRCT. If a participant has an indeterminate usual interstitial pneumonia (UIP) pattern and their HRCT is \>6 months old, if in the opinion of the Investigator their disease has progressed, an additional HRCT may be obtained and reviewed for eligibility.
* 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 Exclusion Criteria:

* Abnormalities detected on electrocardiogram (ECG) of either rhythm or conduction that in the opinion of the Investigator are clinical significant. Participants with implantable cardiovascular devices (for example, pacemaker) affecting the QT interval time may be enrolled in the study based upon Investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the Medical Monitor.
* 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 (for example, connective tissue disease, sarcoidosis and amyloidosis), exposures (for example, radiation, silica, asbestos, and coal dust), or drugs (for example, amiodarone).
* 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 equivalent to prednisone \>10 milligrams (mg)/day or equivalent within 2 weeks prior to Screening.
* Use of any of the following therapies within 4 weeks prior to Screening and during the Screening Period, 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 steady dose \>10 mg/day or equivalent, or other investigational therapy.
* 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.

Where this trial is running

Camperdown, New South Wales and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Idiopathic Pulmonary Fibrosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.