MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT06132256
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
135 participants
INTERVENTIONAL
2023-12-11
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Axatilimab
Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.
Axatilimab
Administered as intravenous (IV) infusion
Placebo
Participants will receive placebo every 2 weeks during the 26-week Treatment Period.
Placebo
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.
Interventions
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Axatilimab
Administered as intravenous (IV) infusion
Placebo
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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DevPro Biopharma
INDUSTRY
Syndax Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Syndax Pharmaceuticals
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Wallace Street Specialist Centre
Brisbane, Queensland, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
Mackay Hospital & Health Service
West Mackay, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
St Vincent's Melbourne
Fitzroy, Victoria, Australia
Institute for Respiratory Health
Perth, Western Australia, Australia
OLV Hospital Aalst
Aalst, Oost-Vlaanderen, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium
Centre de Recherche Clinique - CHUS
Sherbrooke, Quebec, Canada
Dynamic Drug Advancement
Ajax, , Canada
Thomayer University Hospital
Prague, , Czechia
Chu Brest
Brest, , France
CHU Dijon
Dijon, , France
CHU de Rennes
Rennes, , France
Klinikum Konstanz, Innere Medizin, Pneumologie
Konstanz, Baden-Wurttemberg, Germany
Pneumologisches Studienzentrum München-West
Munich, Bavaria, Germany
Studienzentrum Dr. Claus Keller
Frankfurt am Main, Hessia, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
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, Italy
GB Morgagni Hospital
Forlì, FC, Italy
ASST Santi Paolo e Carlo
Milan, Lombardy, Italy
San Gerardo
Monza, MB, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Torino, Orbassano, Italy
University of Padua
Padua, Padua, Italy
Azienda Ospedaliera Universitaria Senese
Siena, Tuscany, Italy
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, Poland
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
University of Medicine and Pharmacy "Victor Babes" Timisoara Department of Pneumology
Timișoara, , Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara Department of Pneumology
Timișoara, , Romania
Inje University Haeundae Paik Hospital
Haeundae, Busan, South Korea
Chonnam National University Hospital
Gwangju, Dong-gu, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea
Konkuk University Medical Center
Seoul, Gwangjin-gu, South Korea
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, Gwangmyeong-si, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Asian Medical Center
Seoul, Songpa-gu, South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Korea University ANAM Hospital
Seoul, , South Korea
SoonChunHyang University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department
Cadiz, , Spain
Giromed Institute
Girona, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital Gregorio Marañon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
E-Da Hospital
Kaohsiung City, , Taiwan
Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
Linkou District, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Royal Papworth Hospital - Clincial Research Facility
Cambridge, Cambridgehsire, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxforshire, United Kingdom
Gannochy Trust Clinical Research Suite
Perth, Scotland, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, W York, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Hull University Teaching Hospitals NHS Trust (Castle Hill)
Cottingham, YS, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2022-502954-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
SNDX-6352-0506
Identifier Type: -
Identifier Source: org_study_id