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Monoclonal Antibodies
Axatilimab for Pulmonary Fibrosis
Phase 2
Recruiting
Research Sponsored by Syndax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
DLco ≥30% and ≤90% of predicted, corrected for hemoglobin at first Screening Visit
Must not have
Receiving nintedanib in combination with pirfenidone
Female participant who is pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 26
Summary
"This trial will look at how well and how safe axatilimab is for people with IPF."
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, side effects from Axatilimab could include typical drug reactions such as headaches, nausea, allergic responses, or more specific effects related to its action on the immune system which will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with IPF according to the 2018 guidelines.
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My lung function test results are within the required range.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking nintedanib and pirfenidone together.
Select...
I am currently pregnant or breastfeeding.
Select...
I have lung disease linked to a specific cause or medication.
Select...
I have smoked cigarettes or vaped in the last 3 months.
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I haven't taken high doses of steroids like prednisone (more than 10 mg/day) in the last 2 weeks.
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My lung scans show more emphysema than fibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Time to disease progression
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AxatilimabExperimental Treatment1 Intervention
Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo every 2 weeks during the 26-week Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axatilimab
2017
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,559 Total Patients Enrolled
DevPro BiopharmaUNKNOWN
4 Previous Clinical Trials
603 Total Patients Enrolled