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New drug shows promise in slowing lung scarring

NCT ID NCT06132256

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called axatilimab in 145 people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. The goal is to see if the drug can slow down the decline in lung function over 26 weeks compared to a placebo. Participants will be randomly assigned to receive either axatilimab or a dummy treatment, and their breathing will be closely monitored.

Why investors are watching

Syndax Pharmaceuticals is running a Phase 2 trial of axatilimab in 145 patients with idiopathic pulmonary fibrosis, a lung disease with no cure. For a small company, this readout matters because axatilimab is a new approach to a disease where current treatments only slow decline, and the result will show whether the drug deserves further development.

If it works: A positive result could position axatilimab as a serious candidate for IPF, opening a path to larger trials and a potential new treatment option. That would broaden Syndax's pipeline beyond its existing programs.

If it fails: A failure or delay would set back the program and could hurt the company's prospects, since Phase 2 trials in IPF often fail to show benefit. Syndax would need to reassess its investment in axatilimab.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

145 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Catania, 95123, Italy

  • AOU Città della Salute e della Scienza di Torino - Molinette

    Molinette, Italy

  • AOU di Modena

    Modena, 41124, Italy

  • ASST Santi Paolo e Carlo

    Milan, Lombardy, 20142, Italy

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500, Belgium

  • Asian Medical Center

    Seoul, Songpa-gu, 05505, South Korea

  • Asklepios Lungenklinik Gauting

    Gauting, 82131, Germany

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Torino, Orbassano, 10043, Italy

  • Azienda Ospedaliera Universitaria Senese

    Siena, Tuscany, 53100, Italy

  • Azienda Ospedaliero Universitaria di Careggi

    Florence, 50134, Italy

  • CHU Amiens

    Amiens, 80054, France

  • CHU Dijon

    Dijon, 21000, France

  • CHU de Rennes

    Rennes, 35033, France

  • Centre de Recherche Clinique - CHUS

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

    Linkou District, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hospital

    Gwangju, Dong-gu, 61469, South Korea

  • Chu Brest

    Brest, 29200, France

  • Chung-Ang University Gwangmyeong Hospital

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

  • Clinica Lavinia Davidescu SRL

    Oradea, 410163, Romania

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

    Timișoara, 300310, Romania

  • Dynamic Drug Advancement

    Ajax, L1S 2J5, Canada

  • E-Da Hospital

    Kaohsiung City, 824005, Taiwan

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565, South Korea

  • Gannochy Trust Clinical Research Suite

    Perth, Scotland, PH11NX, United Kingdom

  • Giromed Institute

    Girona, 17003, Spain

  • Griffith University Clinical Trial Unit

    Southport, Queensland, 4222, Australia

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120, Spain

  • Hospital Universitario Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department

    Cadiz, 11009, Spain

  • Hospital Universitario Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • ISMETT

    Palermo, 90127, Italy

  • Inje University Haeundae Paik Hospital

    Haeundae, Busan, 48108, South Korea

  • Institute for Respiratory Health

    Perth, Western Australia, 6009, Australia

  • Jeonbuk National University Hospital

    Jeonju, 54907, South Korea

  • Klinikum Chemnitz - Zentrum für klinische Studien

    Chemnitz, 09116, Germany

  • Klinikum Konstanz, Innere Medizin, Pneumologie

    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Konkuk University Medical Center

    Seoul, Gwangjin-gu, 05030, South Korea

  • Korea University ANAM Hospital

    Seoul, 02841, South Korea

  • Leeds Teaching Hospitals NHS Trust

    Leeds, W York, LS9 7TF, United Kingdom

  • Mackay Hospital & Health Service

    West Mackay, Queensland, 4740, Australia

  • Makowskie Centrum medyczne Hamernia Sp zz

    Maków Podhalański, 34-220, Poland

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101, Australia

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Mics Centrum Medyczne Bydgoszcz

    Bydgoszcz, Poland

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • OLV Hospital Aalst

    Aalst, Oost-Vlaanderen, 9300, Belgium

  • Ospedale Colonnello D'Avanzo

    Foggia, Apulia, 71122, Italy

  • Oxford University Hospitals NHS Trust

    Oxford, Oxforshire, OX3 7LE, United Kingdom

  • Pneumologisches Studienzentrum München-West

    Munich, Bavaria, 81241, Germany

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022, Germany

  • Royal Papworth Hospital - Clincial Research Facility

    Cambridge, Cambridgehsire, CB2 0AY, United Kingdom

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Gerardo

    Monza, MB, 20900, Italy

  • SoonChunHyang University Hospital

    Seoul, 04401, South Korea

  • Studienzentrum Dr. Keller

    Frankfurt am Main, 60389, Germany

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

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

    Seoul, Eunpyeong-gu, 03312, South Korea

  • Thomayer University Hospital

    Prague, 140 00, Czechia

  • University Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2WB, United Kingdom

  • University of Padua

    Padova, Padua, 35128, Italy

  • Vitamed Galaj I Cichomski sp.j.

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

  • Wallace Street Specialist Centre

    Brisbane, Queensland, 4032, Australia

  • Warmia and Mazury Center for Lung Diseases

    Olsztyn, 10-357, Poland

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