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

NCT06132256 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: SNDX-6352-05062022-502954-15-00
• Study Type: interventional
• Target: 145
• Locations: 13 countries
• Sites: 78

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])

  Baseline through Week 26

Secondary Outcomes (4)

• Time to disease progression

  Baseline through Week 26

• Annualized rate of decline in FVC percent predicted over 26 weeks

  Baseline through Week 26

• Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26

  Baseline, Week 26

• Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26

  Baseline, Week 26

Study Arms (2)

Axatilimab

EXPERIMENTAL

Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.

Drug: Axatilimab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo every 2 weeks during the 26-week Treatment Period.

Other: Placebo

Interventions

Axatilimab DRUG

Administered as intravenous (IV) infusion

Also known as: Niktimvo, SNDX-6352

Axatilimab

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syndax Pharmaceuticals: lead
• DevPro Biopharma: collaborator

Study Sites (78)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Wallace Street Specialist Centre

Brisbane, Queensland, 4032, Australia

Location

Mater Misericordiae Ltd

South Brisbane, Queensland, 4101, Australia

Location

Griffith University Clinical Trial Unit

Southport, Queensland, 4222, Australia

Location

Mackay Hospital & Health Service

West Mackay, Queensland, 4740, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Institute for Respiratory Health

Perth, Western Australia, 6009, Australia

Location

OLV Hospital Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

Centre de Recherche Clinique - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Dynamic Drug Advancement

Ajax, L1S 2J5, Canada

Location

Thomayer University Hospital

Prague, 140 00, Czechia

Location

CHU Amiens

Amiens, 80054, France

Location

Chu Brest

Brest, 29200, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU de Rennes

Rennes, 35033, France

Location

Klinikum Konstanz, Innere Medizin, Pneumologie

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

Pneumologisches Studienzentrum München-West

Munich, Bavaria, 81241, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Klinikum Chemnitz - Zentrum für klinische Studien

Chemnitz, 09116, Germany

Location

Studienzentrum Dr. Keller

Frankfurt am Main, 60389, Germany

Location

Asklepios Lungenklinik Gauting

Gauting, 82131, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Ospedale Colonnello D'Avanzo

Foggia, Apulia, 71122, Italy

Location

ASST Santi Paolo e Carlo

Milan, Lombardy, 20142, Italy

Location

San Gerardo

Monza, MB, 20900, Italy

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Torino, Orbassano, 10043, Italy

Location

University of Padua

Padua, Padua, 35128, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Tuscany, 53100, Italy

Location

A.O.U. Policlinico "G. Rodolico - San Marco"

Catania, 95123, Italy

Location

Azienda Ospedaliero Universitaria di Careggi

Florence, 50134, Italy

Location

AOU di Modena

Modena, 41124, Italy

Location

AOU Città della Salute e della Scienza di Torino - Molinette

Molinette, Italy

Location

ISMETT

Palermo, 90127, Italy

Location

Vitamed Galaj I Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

Location

Mics Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Location

Makowskie Centrum medyczne Hamernia Sp zz

Maków Podhalański, 34-220, Poland

Location

Warmia and Mazury Center for Lung Diseases

Olsztyn, 10-357, Poland

Location

Clinica Lavinia Davidescu SRL

Oradea, 410163, Romania

Location

Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara Department of Pneumology

Timișoara, 300310, Romania

Location

Inje University Haeundae Paik Hospital

Haeundae, Busan, 48108, South Korea

Location

Chonnam National University Hospital

Gwangju, Dong-gu, 61469, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, 03312, South Korea

Location

Konkuk University Medical Center

Seoul, Gwangjin-gu, 05030, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeong-si, 14353, South Korea

Location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

Asian Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Korea University ANAM Hospital

Seoul, 02841, South Korea

Location

SoonChunHyang University Hospital

Seoul, 04401, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department

Cadiz, 11009, Spain

Location

Giromed Institute

Girona, 17003, Spain

Location

Hospital Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

E-Da Hospital

Kaohsiung City, 824005, Taiwan

Location

Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Royal Papworth Hospital - Clincial Research Facility

Cambridge, Cambridgehsire, CB2 0AY, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, Oxforshire, OX3 7LE, United Kingdom

Location

Gannochy Trust Clinical Research Suite

Perth, Scotland, PH11NX, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, W York, LS9 7TF, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2WB, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

axatilimab

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Syndax Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); PL (4); RO (2); ES (15); CA (2); KR (11); TW (5); CZ (1); GB (6); IT (11); DE (7); AU (8); FR (4)