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ACTIVE NOT RECRUITING

NCT06132256

PHASE2

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

Sponsor: Syndax Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

145

Start Date

2023-12-11

Completion Date

2026-11

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

DRUG

Axatilimab

Administered as intravenous (IV) infusion

OTHER

Placebo

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

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.

Locations (78)

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

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 Amiens

Amiens, France

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

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

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

Padova, 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

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 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

China Medical University Hospital

Taichung, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (78)