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Clinical Trials in China / NCT06132256
Active, not recruiting Phase 2

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

NCT06132256 · tracked via the Priya Life Science China tracker
Sponsor
Syndax Pharmaceuticals
Phase
Phase 2
Started
2023-12-11
Last updated
2026-03-27

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

AxatilimabPlacebo

Axatilimab: Administered as intravenous (IV) infusion

Placebo: Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Camperdown New South Wales
Sunshine Coast University Hospital Birtinya Queensland
Wallace Street Specialist Centre Brisbane Queensland
Mater Misericordiae Ltd South Brisbane Queensland
Griffith University Clinical Trial Unit Southport Queensland
Mackay Hospital & Health Service West Mackay Queensland
Monash Health Clayton Victoria
Institute for Respiratory Health Perth Western Australia
OLV Hospital Aalst Aalst Oost-Vlaanderen
AZ Groeninge Kortrijk West-Vlaanderen
Centre de Recherche Clinique - CHUS Sherbrooke Quebec
Dynamic Drug Advancement Ajax Canada
Thomayer University Hospital Prague Czechia
CHU Amiens Amiens France
Chu Brest Brest France
CHU Dijon Dijon France
CHU de Rennes Rennes France
Klinikum Konstanz, Innere Medizin, Pneumologie Konstanz Baden-Wurttemberg
Pneumologisches Studienzentrum München-West Munich Bavaria
Medizinische Hochschule Hannover Hanover Lower Saxony
Klinikum Chemnitz - Zentrum für klinische Studien Chemnitz Germany
Studienzentrum Dr. Keller Frankfurt am Main Germany
Asklepios Lungenklinik Gauting Gauting Germany
RoMed Klinikum Rosenheim Rosenheim Germany
Ospedale Colonnello D'Avanzo Foggia Apulia
ASST Santi Paolo e Carlo Milan Lombardy
San Gerardo Monza MB
Azienda Ospedaliera Universitaria San Luigi Gonzaga Torino Orbassano
University of Padua Padova Padua
Azienda Ospedaliera Universitaria Senese Siena Tuscany
A.O.U. Policlinico "G. Rodolico - San Marco" Catania Italy
Azienda Ospedaliero Universitaria di Careggi Florence Italy
AOU di Modena Modena Italy
AOU Città della Salute e della Scienza di Torino - Molinette Molinette Italy
ISMETT Palermo Italy
Vitamed Galaj I Cichomski sp.j. Bydgoszcz Kuyavian-Pomeranian Voivodeship
Mics Centrum Medyczne Bydgoszcz Bydgoszcz Poland
Makowskie Centrum medyczne Hamernia Sp zz Maków Podhalański Poland
Warmia and Mazury Center for Lung Diseases Olsztyn Poland
Clinica Lavinia Davidescu SRL Oradea Romania

+ 38 more sites — see the full list on the official registry below.

More Syndax Pharmaceuticals trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06132256 on ClinicalTrials.gov ↗ ← All trials in China