Clinical trial NCT06132256: MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Syndax Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: DevPro Biopharma
First posted: 2023-11-15
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])
timeFrame: Baseline through Week 26
Secondary outcomes:
measure: Time to disease progression
timeFrame: Baseline through Week 26
measure: Annualized rate of decline in FVC percent predicted over 26 weeks
timeFrame: Baseline through Week 26
measure: Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Wallace Street Specialist Centre
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd
state: Queensland
city: Southport
country: Australia
facility: Griffith University Clinical Trial Unit
state: Queensland
city: West Mackay
country: Australia
facility: Mackay Hospital & Health Service
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Melbourne
state: Victoria
city: Perth
country: Australia
facility: Institute for Respiratory Health
state: West Australia
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
state: Oost-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Sherbrooke
country: Canada
facility: Centre de Recherche Clinique - CHUS
state: Quebec
city: Prague
country: Czechia
facility: Thomayer University Hospital
city: Brest
country: France
facility: Chu Brest
city: Dijon
country: France
facility: CHU Dijon
city: Rennes
country: France
facility: CHU de Rennes
city: Konstanz
country: Germany
facility: Klinikum Konstanz, Innere Medizin, Pneumologie
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: Pneumologisches Studienzentrum München-West
state: Bavaria
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Lower Saxony
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz - Zentrum für klinische Studien
city: Gauting
country: Germany
facility: Asklepios Lungenklinik Gauting
city: Foggia
country: Italy
facility: Ospedale Colonnello D'Avanzo
state: Apulie
city: Forlì
country: Italy
facility: GB Morgagni Hospital
state: FC
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
state: Lombardia
city: Monza
country: Italy
facility: San Gerardo
state: MB
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: MI
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
state: Orbassano
city: Padova
country: Italy
facility: University of Padua
state: Padua
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
state: Tuscany
city: Catania
country: Italy
facility: A.O.U. Policlinico "G. Rodolico - San Marco"
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria di Careggi
city: Modena
country: Italy
facility: AOU di Modena
city: Molinette
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Molinette
city: Palermo
country: Italy
facility: ISMETT
city: Rome
country: Italy
facility: Policlinico Tor Vergata Rome
city: Haeundae
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Dong-gu
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
state: Eunpyeong-gu
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Gwangjin-gu
city: Gyeonggi-do
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
state: Gwangmyeong-si
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
city: Seoul
country: Korea, Republic of
facility: Asian Medical Center
state: Songpa-gu
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University ANAM Hospital
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj I Cichomski sp.j.
state: Kujawsko-Pomorskie
city: Olsztyn
country: Poland
facility: Warmia and Mazury Center for Lung Diseases
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Tauli
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department
city: Girona
country: Spain
facility: Giromed Institute
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Linkou
country: Taiwan
facility: Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital - Clincial Research Facility
state: Cambridgehsire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxforshire
city: Perth
country: United Kingdom
facility: Gannochy Trust Clinical Research Suite
state: Scotland
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: W York
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: West Midlands
city: Cottingham
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust (Castle Hill)
state: YS
Study officials:
References: