AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 2NCT06132256

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

A Phase 2 study testing Axatilimab in people with Idiopathic Pulmonary Fibrosis, run by Syndax Pharmaceuticals at 78 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study will evaluate the efficacy and safety of axatilimab in participants with IPF. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Axatilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
145 participants
Where
78 sitesin 13 countries
Study dates
11 Dec 2023to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

78 sites in 13 countries.

78 sites in 13 countries

Spain15 sites

  • University Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

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

    Cadiz, 11009

  • Giromed Institute

    Girona, 17003

  • Hospital Universitario Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Universitario Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

Other trials in Spain

Italy11 sites

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

    Catania, 95123

  • Azienda Ospedaliero Universitaria di Careggi

    Florence, 50134

  • Ospedale Colonnello D'Avanzo

    Foggia, Apulia, 71122

  • ASST Santi Paolo e Carlo

    Milan, Lombardy, 20142

  • AOU di Modena

    Modena, 41124

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

    Molinette

  • San Gerardo

    Monza, MB, 20900

  • University of Padua

    Padova, Padua, 35128

  • ISMETT

    Palermo, 90127

  • Azienda Ospedaliera Universitaria Senese

    Siena, Tuscany, 53100

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Torino, Orbassano, 10043

Other trials in Italy

South Korea11 sites

  • Chonnam National University Hospital

    Gwangju, Dong-gu, 61469

  • Chung-Ang University Gwangmyeong Hospital

    Gyeonggi-do, Gwangmyeong-si, 14353

  • Inje University Haeundae Paik Hospital

    Haeundae, Busan, 48108

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565

  • Jeonbuk National University Hospital

    Jeonju, 54907

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

    Seoul, Eunpyeong-gu, 03312

  • Konkuk University Medical Center

    Seoul, Gwangjin-gu, 05030

  • Asian Medical Center

    Seoul, Songpa-gu, 05505

  • Korea University ANAM Hospital

    Seoul, 02841

  • SoonChunHyang University Hospital

    Seoul, 04401

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Australia8 sites

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Wallace Street Specialist Centre

    Brisbane, Queensland, 4032

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Health

    Clayton, Victoria, 3168

  • Institute for Respiratory Health

    Perth, Western Australia, 6009

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

  • Griffith University Clinical Trial Unit

    Southport, Queensland, 4222

  • Mackay Hospital & Health Service

    West Mackay, Queensland, 4740

Other trials in Australia

Germany7 sites

  • Klinikum Chemnitz - Zentrum für klinische Studien

    Chemnitz, 09116

  • Studienzentrum Dr. Keller

    Frankfurt am Main, 60389

  • Asklepios Lungenklinik Gauting

    Gauting, 82131

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Klinikum Konstanz, Innere Medizin, Pneumologie

    Konstanz, Baden-Wurttemberg, 78464

  • Pneumologisches Studienzentrum München-West

    Munich, Bavaria, 81241

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

Other trials in Germany

United Kingdom6 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2WB

  • Royal Papworth Hospital - Clincial Research Facility

    Cambridge, Cambridgehsire, CB2 0AY

  • Leeds Teaching Hospitals NHS Trust

    Leeds, W York, LS9 7TF

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY

  • Oxford University Hospitals NHS Trust

    Oxford, Oxforshire, OX3 7LE

  • Gannochy Trust Clinical Research Suite

    Perth, Scotland, PH11NX

Other trials in United Kingdom

Taiwan5 sites

  • E-Da Hospital

    Kaohsiung City, 824005

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

    Linkou District

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

France4 sites

  • CHU Amiens

    Amiens, 80054

  • Chu Brest

    Brest, 29200

  • CHU Dijon

    Dijon, 21000

  • CHU de Rennes

    Rennes, 35033

Other trials in France

Poland4 sites

  • Vitamed Galaj I Cichomski sp.j.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Mics Centrum Medyczne Bydgoszcz

    Bydgoszcz

  • Makowskie Centrum medyczne Hamernia Sp zz

    Maków Podhalański, 34-220

  • Warmia and Mazury Center for Lung Diseases

    Olsztyn, 10-357

Other trials in Poland

Belgium2 sites

  • OLV Hospital Aalst

    Aalst, Oost-Vlaanderen, 9300

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

Other trials in Belgium

Canada2 sites

  • Dynamic Drug Advancement

    Ajax, L1S 2J5

  • Centre de Recherche Clinique - CHUS

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Romania2 sites

  • Clinica Lavinia Davidescu SRL

    Oradea, 410163

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

    Timișoara, 300310

Other trials in Romania

Czechia1 site

  • Thomayer University Hospital

    Prague, 140 00

Other trials in Czechia

About this study

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)

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

Being tested
Axatilimab, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AxatilimabDrug

    Also called Niktimvo, SNDX-6352

    Administered as intravenous (IV) infusion

  • PlaceboOther

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

Study groups in NCT06132256
Study groupRoleWhat they receive
AxatilimabExperimentalParticipants will receive axatilimab every 2 weeks during the 26-week Treatment Period.
Receives: Drug: Axatilimab
PlaceboPlacebo comparatorParticipants will receive placebo every 2 weeks during the 26-week Treatment Period.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline through Week 26

Secondary outcomes (4)

  1. Time to disease progression

    Disease progression is defined as absolute FVC percent predicted decline of ≥10%, or occurrence of lung transplant or all-cause death prior to Week 26.

    Measured: Baseline through Week 26

  2. Annualized rate of decline in FVC percent predicted over 26 weeks

    Measured: Baseline through Week 26

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

    Measured: Baseline, Week 26

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

    Measured: Baseline, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start11 Dec 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132256
Sponsor's protocol ID
SNDX-6352-0506
Other IDs
2022-502954-15-00
Status last verified
Mar 2026
First submitted
9 Nov 2023
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Axatilimab in people with Idiopathic Pulmonary Fibrosis, run by Syndax Pharmaceuticals at 78 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Spain, Italy, South Korea, Australia, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL]) (time frame: Baseline through Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06132256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in