Axatilimab for Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+76 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Syndax Pharmaceuticals

Must not be taking: Nintedanib, Pirfenidone, Corticosteroids, others

Disqualifiers: Emphysema, Connective tissue disease, others

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The study will evaluate the efficacy and safety of axatilimab in participants with IPF.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as nintedanib with pirfenidone, systemic corticosteroids over 10 mg/day, and several other specific drugs, at least 4 weeks before screening. It's best to discuss your current medications with the trial team to see if any need to be stopped.

What makes the drug Axatilimab unique for treating pulmonary fibrosis?

Axatilimab is unique because it targets specific pathways involved in pulmonary fibrosis, potentially offering a new approach compared to existing treatments like bosentan and pirfenidone, which have shown limited effectiveness or are still under investigation for this condition. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for people with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring. Participants must have an FVC (a measure of lung function) at or above 45% of the expected value, a confirmed diagnosis following specific guidelines, and recent chest scans that meet study standards. They should also have certain levels of other breathing measures within set limits.

Inclusion Criteria

I have been diagnosed with IPF according to the 2018 guidelines.

FVC ≥45% of predicted normal at Screening Visits

Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 at Screening Visits

Exclusion Criteria

I am currently taking nintedanib and pirfenidone together.

I am currently pregnant or breastfeeding.

Participants who cannot meet protocol-specified baseline stability criteria

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive axatilimab or placebo every 2 weeks during the 26-week Treatment Period

26 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Axatilimab (Monoclonal Antibodies)

Trial Overview The MAXPIRe study is testing Axatilimab against a placebo to see if it's effective and safe for treating IPF. Participants will be randomly assigned to receive either the actual medication or a placebo in order to compare outcomes between the two groups.

Participant Groups

Group I: Axatilimab Experimental Treatment 1 Intervention

Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo every 2 weeks during the 26-week Treatment Period.

Axatilimab is already approved in United States for the following indications:

🇺🇸 Approved in United States as Axatilimab for:

• Chronic Graft-Versus-Host Disease

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre de Recherche Clinique - CHUS Québec, Canada

Centre de Recherche Clinique - CHUS Sherbrooke, Canada

Who Is Running the Clinical Trial?

Syndax Pharmaceuticals

Lead Sponsor

Trials

49

Patients Recruited

2,700+

DevPro Biopharma

Collaborator

Trials

5

Patients Recruited

800+

DevPro Biopharma

Industry Sponsor

Trials

5

Patients Recruited

800+

References

1. England pubmed.ncbi.nlm.nih.gov

Bosentan for idiopathic pulmonary fibrosis. [2018] Idiopathic pulmonary fibrosis (IPF) is a debilitating, fatal, chronic fibrosing lung disease with no known effective therapy. Endothelin-1 may underlie the pathogenesis of lung fibrosis, therefore it was hypothesized that the oral dual endothelin receptor antagonist bosentan may have efficacy for the treatment of IPF. The BUILD-1 study evaluated the efficacy, safety and tolerability of bosentan in patients with IPF. Bosentan was associated with a trend toward delayed time to disease progression or death and improvement in quality-of-life, both of which were more pronounced in patients with a biopsy-confirmed IPF diagnosis. These observations are being investigated in the ongoing BUILD-3 trial.

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of bosentan for idiopathic pulmonary fibrosis. [2010] Idiopathic pulmonary fibrosis (IPF) is a quality-of-life-altering and life-shortening lung disease manifested by physiologic restriction, hypoxemia and progressive shortness of breath. Despite nearly 30 years of investigation, the median survival for patients with this disease remains dismal at approximately 3 years from the time of diagnosis. Recent investigations have identified a number of potential molecular therapeutic targets for IPF that include endothelin-1 and other fibrogenic cytokines. Bosentan, a nonselective endothelin receptor antagonist approved in the USA and Europe for the treatment of patients with pulmonary arterial hypertension, is currently undergoing evaluation as a potential therapy for IPF. A recently completed multinational, placebo-controlled trial failed to show a beneficial impact of bosentan on the primary end point, but results from a hypothesis-generating, post hoc analysis of data from this trial have prompted an assessment of the drug for efficacy in a selected subgroup of IPF patients - those with biopsy-proven IPF and little radiographic honeycombing. Results from this trial are anticipated in 2009.

3. England pubmed.ncbi.nlm.nih.gov

Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial. [2014] Idiopathic pulmonary fibrosis is a progressive, fatal disease. This prospective, randomised, double-blind, multicentre, parallel-group, placebo-controlled phase II trial (NCT00903331) investigated the efficacy and safety of the endothelin receptor antagonist macitentan in idiopathic pulmonary fibrosis. Eligible subjects were adults with idiopathic pulmonary fibrosis of

4. England pubmed.ncbi.nlm.nih.gov

Astilbin ameliorates pulmonary fibrosis via blockade of Hedgehog signaling pathway. [2019] The nature of pulmonary fibrosis involves inadequate repair of the epithelial cell barrier accompanied by impaired regulation of the fibroblast. Moreover, pulmonary fibrosis currently lacks an effective therapeutic drug. This study targets the protection of the epithelial cell and fibroblast to identify a novel, potentially therapeutic drug (i.e., astilbin).

5. United States pubmed.ncbi.nlm.nih.gov

Pirfenidone Initiates a New Era in the Treatment of Idiopathic Pulmonary Fibrosis. [2016] Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fatal disease that has long eluded therapy. Prognosis remains very poor, and currently lung transplantation offers the only hope of survival. Recently, great strides have been made in the development of pharmaceutical therapy to treat IPF. Pirfenidone, an oral antifibrotic agent, has been shown to slow progression of the disease and improve progression-free survival, offering new hope for patients suffering from IPF.