New drug shows promise in slowing lung scarring
NCT ID NCT06132256
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic pulmonary fibrosis are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Patients and families build a living database of pulmonary fibrosis
- Can pulmonary fibrosis patients pull hard enough for their inhalers?
- Can a thousand patient records unlock better care for a rare lung disease?
- Sharper CT scans may solve a lung disease diagnostic puzzle
- Can we untangle the overlap of lung diseases? a new study aims to find out
- A blood test that could predict who survives a lung disease crisis?