MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT06132256
- Lead Sponsor
- Syndax Pharmaceuticals
- Brief Summary
The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Axatilimab Axatilimab Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period. Placebo Placebo Participants will receive placebo every 2 weeks during the 26-week Treatment Period.
- Primary Outcome Measures
Name Time Method Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL]) Baseline through Week 26
- Secondary Outcome Measures
Name Time Method 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 Time to disease progression Baseline through Week 26 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.
Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26 Baseline, Week 26
Trial Locations
- Locations (69)
Policlinico Tor Vergata Rome
🇮🇹Rome, Italy
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
ISMETT
🇮🇹Palermo, Italy
Mackay Hospital & Health Service
🇦🇺West Mackay, Queensland, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
St Vincent's Melbourne
🇦🇺Fitzroy, Victoria, Australia
Institute for Respiratory Health
🇦🇺Perth, West Australia, Australia
OLV Hospital Aalst
🇧🇪Aalst, Oost-Vlaanderen, Belgium
AZ Groeninge
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Centre de Recherche Clinique - CHUS
🇨🇦Sherbrooke, Quebec, Canada
Thomayer University Hospital
🇨🇿Prague, Czechia
Chu Brest
🇫🇷Brest, France
CHU Dijon
🇫🇷Dijon, France
Klinikum Konstanz, Innere Medizin, Pneumologie
🇩🇪Konstanz, Baden-Wuerttemberg, Germany
Pneumologisches Studienzentrum München-West
🇩🇪Muenchen, Bavaria, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Lower Saxony, Germany
Asklepios Lungenklinik Gauting
🇩🇪Gauting, Germany
Ospedale Colonnello D'Avanzo
🇮🇹Foggia, Apulie, Italy
GB Morgagni Hospital
🇮🇹Forlì, FC, Italy
ASST Santi Paolo e Carlo
🇮🇹Milano, Lombardia, Italy
San Gerardo
🇮🇹Monza, MB, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, MI, 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
🇮🇹Firenze, Italy
AOU di Modena
🇮🇹Modena, Italy
AOU Città della Salute e della Scienza di Torino - Molinette
🇮🇹Molinette, Italy
Inje University Haeundae Paik Hospital
🇰🇷Haeundae, Busan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Dong-gu, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Eunpyeong-gu, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Gwangjin-gu, Korea, Republic of
Chung-Ang University Gwangmyeong Hospital
🇰🇷Gyeonggi-do, Gwangmyeong-si, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Namdong-gu, Korea, Republic of
Asian Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Korea University ANAM Hospital
🇰🇷Seoul, Korea, Republic of
SoonChunHyang University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Vitamed Galaj I Cichomski sp.j.
🇵🇱Bydgoszcz, Kujawsko-Pomorskie, Poland
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Bellvitge
🇪🇸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
University Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department
🇪🇸Cadiz, Spain
Giromed Institute
🇪🇸Girona, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
🇨🇳Linkou, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, 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
Birmingham Heartlands Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Hull University Teaching Hospitals NHS Trust (Castle Hill)
🇬🇧Cottingham, YS, United Kingdom