Axatilimab: Administered as intravenous (IV) infusion
Placebo: Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.
Study summary
The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL]) — Baseline through Week 26
Trial sites (78)
Facility
City
Region
Status
Royal Prince Alfred Hospital
Camperdown
New South Wales
Sunshine Coast University Hospital
Birtinya
Queensland
Wallace Street Specialist Centre
Brisbane
Queensland
Mater Misericordiae Ltd
South Brisbane
Queensland
Griffith University Clinical Trial Unit
Southport
Queensland
Mackay Hospital & Health Service
West Mackay
Queensland
Monash Health
Clayton
Victoria
Institute for Respiratory Health
Perth
Western Australia
OLV Hospital Aalst
Aalst
Oost-Vlaanderen
AZ Groeninge
Kortrijk
West-Vlaanderen
Centre de Recherche Clinique - CHUS
Sherbrooke
Quebec
Dynamic Drug Advancement
Ajax
Canada
Thomayer University Hospital
Prague
Czechia
CHU Amiens
Amiens
France
Chu Brest
Brest
France
CHU Dijon
Dijon
France
CHU de Rennes
Rennes
France
Klinikum Konstanz, Innere Medizin, Pneumologie
Konstanz
Baden-Wurttemberg
Pneumologisches Studienzentrum München-West
Munich
Bavaria
Medizinische Hochschule Hannover
Hanover
Lower Saxony
Klinikum Chemnitz - Zentrum für klinische Studien
Chemnitz
Germany
Studienzentrum Dr. Keller
Frankfurt am Main
Germany
Asklepios Lungenklinik Gauting
Gauting
Germany
RoMed Klinikum Rosenheim
Rosenheim
Germany
Ospedale Colonnello D'Avanzo
Foggia
Apulia
ASST Santi Paolo e Carlo
Milan
Lombardy
San Gerardo
Monza
MB
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Torino
Orbassano
University of Padua
Padova
Padua
Azienda Ospedaliera Universitaria Senese
Siena
Tuscany
A.O.U. Policlinico "G. Rodolico - San Marco"
Catania
Italy
Azienda Ospedaliero Universitaria di Careggi
Florence
Italy
AOU di Modena
Modena
Italy
AOU Città della Salute e della Scienza di Torino - Molinette
Molinette
Italy
ISMETT
Palermo
Italy
Vitamed Galaj I Cichomski sp.j.
Bydgoszcz
Kuyavian-Pomeranian Voivodeship
Mics Centrum Medyczne Bydgoszcz
Bydgoszcz
Poland
Makowskie Centrum medyczne Hamernia Sp zz
Maków Podhalański
Poland
Warmia and Mazury Center for Lung Diseases
Olsztyn
Poland
Clinica Lavinia Davidescu SRL
Oradea
Romania
+ 38 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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