MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

March 25, 2026 updated by: Syndax Pharmaceuticals

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • Brisbane, Queensland, Australia, 4032
        • Wallace Street Specialist Centre
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd
      • Southport, Queensland, Australia, 4222
        • Griffith University Clinical Trial Unit
      • West Mackay, Queensland, Australia, 4740
        • Mackay Hospital & Health Service
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Institute for Respiratory Health
  • Belgium
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
        • OLV Hospital Aalst
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge
  • Canada
      • Ajax, Canada, L1S 2J5
        • Dynamic Drug Advancement
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de Recherche Clinique - CHUS
  • Czechia
      • Prague, Czechia, 140 00
        • Thomayer University Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Brest, France, 29200
        • CHU Brest
      • Dijon, France, 21000
        • CHU Dijon
      • Rennes, France, 35033
        • CHU de Rennes
  • Germany
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz - Zentrum für klinische Studien
      • Frankfurt am Main, Germany, 60389
        • Studienzentrum Dr. Keller
      • Gauting, Germany, 82131
        • Asklepios Lungenklinik Gauting
      • Rosenheim, Germany, 83022
        • RoMed Klinikum Rosenheim
    • Baden-Wurttemberg
      • Konstanz, Baden-Wurttemberg, Germany, 78464
        • Klinikum Konstanz, Innere Medizin, Pneumologie
    • Bavaria
      • Munich, Bavaria, Germany, 81241
        • Pneumologisches Studienzentrum München-West
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover
  • Italy
      • Catania, Italy, 95123
        • A.O.U. Policlinico "G. Rodolico - San Marco"
      • Florence, Italy, 50134
        • Azienda Ospedaliero Universitaria di Careggi
      • Modena, Italy, 41124
        • AOU di Modena
      • Molinette, Italy
        • AOU Città della Salute e della Scienza di Torino - Molinette
      • Palermo, Italy, 90127
        • ISMETT
    • Apulia
      • Foggia, Apulia, Italy, 71122
        • Ospedale Colonnello D'Avanzo
    • Lombardy
      • Milan, Lombardy, Italy, 20142
        • Asst Santi Paolo E Carlo
    • MB
      • Monza, MB, Italy, 20900
        • San Gerardo
    • Orbassano
      • Torino, Orbassano, Italy, 10043
        • Azienda Ospedaliera Universitaria San Luigi Gonzaga
    • Padua
      • Padua, Padua, Italy, 35128
        • University of Padua
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
  • Poland
      • Bydgoszcz, Poland
        • MICS Centrum Medyczne Bydgoszcz
      • Maków Podhalański, Poland, 34-220
        • Makowskie Centrum medyczne Hamernia Sp zz
      • Olsztyn, Poland, 10-357
        • Warmia and Mazury Center for Lung Diseases
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
        • Vitamed Galaj i Cichomski sp.j.
  • Romania
      • Oradea, Romania, 410163
        • Clinica Lavinia Davidescu SRL
      • Timișoara, Romania, 300310
        • Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara Department of Pneumology
  • South Korea
      • Jeonju, South Korea, 54907
        • Jeonbuk National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 04401
        • Soonchunhyang University Hospital
    • Busan
      • Haeundae, Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
    • Dong-gu
      • Gwangju, Dong-gu, South Korea, 61469
        • Chonnam National University Hospital
    • Eunpyeong-gu
      • Seoul, Eunpyeong-gu, South Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    • Gwangjin-gu
      • Seoul, Gwangjin-gu, South Korea, 05030
        • Konkuk University Medical Center
    • Gwangmyeong-si
      • Gyeonggi-do, Gwangmyeong-si, South Korea, 14353
        • Chung-Ang University Gwangmyeong Hospital
    • Namdong-gu
      • Incheon, Namdong-gu, South Korea, 21565
        • Gachon University Gil Medical Center
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea, 05505
        • Asian Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department
      • Girona, Spain, 17003
        • Giromed Institute
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain, 07120
        • Hospital Universitari Son Espases
      • Santiago de Compostela, Spain, 15706
        • Hospital Universitario Santiago de Compostela
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario Bellvitge
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitario Parc Taulí
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
  • Taiwan
      • Kaohsiung City, Taiwan, 824005
        • E-Da Hospital
      • Linkou District, Taiwan
        • Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
    • Cambridgehsire
      • Cambridge, Cambridgehsire, United Kingdom, CB2 0AY
        • Royal Papworth Hospital - Clincial Research Facility
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
    • Oxforshire
      • Oxford, Oxforshire, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Trust
    • Scotland
      • Perth, Scotland, United Kingdom, PH11NX
        • Gannochy Trust Clinical Research Suite
    • W York
      • Leeds, W York, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2WB
        • University Hospitals Birmingham NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Axatilimab
Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.
Drug: Axatilimab
Administered as intravenous (IV) infusion
Other Names:
  • SNDX-6352
  • Niktimvo
Placebo Comparator: Placebo
Participants will receive placebo every 2 weeks during the 26-week Treatment Period.
Other: Placebo
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])
Time Frame: Baseline through Week 26
Baseline through Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to disease progression
Time Frame: Baseline through Week 26
Disease progression is defined as absolute FVC percent predicted decline of ≥10%, or occurrence of lung transplant or all-cause death prior to Week 26.
Baseline through Week 26
Annualized rate of decline in FVC percent predicted over 26 weeks
Time Frame: Baseline through Week 26
Baseline through Week 26
Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26
Time Frame: Baseline, Week 26
Baseline, Week 26
Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26
Time Frame: Baseline, Week 26
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Syndax Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DevPro Biopharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Syndax Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SNDX-6352-0506
  • 2022-502954-15-00 (Other Identifier: EU-CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings