Study on Axatilimab for Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring of the lungs, making it difficult to breathe. The treatment being tested is called Axatilimab, which is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream. The study will compare the effects of Axatilimab to a placebo to understand its impact on lung function over a period of 26 weeks.

The purpose of the study is to evaluate how Axatilimab affects lung function in people with IPF. Participants will be randomly assigned to receive either Axatilimab or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will last for 26 weeks, during which participants will have regular check-ups to monitor their lung function and overall health.

Throughout the study, researchers will measure the rate of decline in lung capacity, which is how much air the lungs can hold, and observe any changes in symptoms or disease progression. The study aims to provide valuable information on the safety and effectiveness of Axatilimab as a potential treatment for IPF, helping to improve the quality of life for those affected by this condition.

1 randomization and initial assessment

Upon joining the study, you will be randomly assigned to receive either the investigational medication, axatilimab, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

An initial assessment will be conducted to establish baseline measurements of your lung function. This includes tests such as forced vital capacity (FVC) and diffusion capacity for carbon monoxide (DLCO).

2 treatment administration

The treatment involves receiving an intravenous infusion. The specific schedule and dosage will be determined by the study protocol, and you will be informed of the exact timing and frequency of these infusions.

The treatment period lasts for 26 weeks, during which you will continue to receive either axatilimab or placebo.

3 ongoing assessments

Throughout the 26-week period, regular assessments will be conducted to monitor your lung function and overall health. These assessments will include repeated measurements of FVC and DLCO.

You will also be asked to complete questionnaires, such as the St. George’s Respiratory Questionnaire (SGRQ), to evaluate changes in your respiratory symptoms and quality of life.

4 end of treatment evaluation

At the end of the 26-week treatment period, a final evaluation will be conducted to assess the effects of the treatment on your lung function and overall health.

This evaluation will include the same tests and questionnaires used during the initial and ongoing assessments.

Who Can Join the Study?

  • Must be a male or female aged 40 years or older on the day of signing the consent form.
  • Must be able to give signed informed consent and agree to follow the study requirements.
  • Must have considered all other treatment options, including possible lung transplantation, before joining the study.
  • Must have a documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF), which is a lung condition, according to specific guidelines.
  • Must have a High-Resolution Computed Tomography (HRCT) scan confirming the IPF diagnosis. This is a detailed type of lung scan.
  • Must meet specific criteria based on lung scan patterns or have a lung biopsy that supports the diagnosis.
  • Must meet one of the following medication criteria for IPF:
    • Never taken certain IPF medications like nintedanib or pirfenidone, or stopped them for specific reasons.
    • If taking these medications, must have been on a stable dose for at least 12 weeks before the study.
    • If previously taken and stopped these medications, must have stopped at least 4 weeks before the study.
  • Must meet specific lung function criteria during the screening period, including:
    • Forced Vital Capacity (FVC) of at least 45% of the predicted normal value. FVC is a measure of lung capacity.
    • Forced Expiratory Volume in 1 second (FEV1) to FVC ratio of at least 0.7. This measures how well you can exhale.
    • Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) between 30% and 90% of predicted, adjusted for hemoglobin levels. This measures how well your lungs transfer oxygen.
    • Must be able to perform acceptable lung function tests.
  • Must have an estimated life expectancy of at least 12 months for conditions not related to IPF.
  • Male and female participants of childbearing potential must agree to use highly effective birth control methods during the study and for 90 days after the last dose. This includes not donating eggs or sperm during this time.
  • Must be able to comply with the study requirements according to the investigator’s judgment.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Romed Klinikum Rosenheim Rosenheim Germany
Azienda Ospedaliera di Padova Padua Italy
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
Virgen del Rocío University Hospital Sevilla Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Clinic De Barcelona Barcelona Spain
Klinikum Chemnitz gGmbH Chemnitz Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Klinikum Konstanz GmbH Konstanz Germany
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. Palermo Italy
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Giromed Institute S.L.P. Barcelona Spain
Fakultni Thomayerova nemocnice Prague Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Pneumological Study Center Munich West Munich Germany
Huxqntao Uawwqvubvylja Mhdwhqb Do Vzhtnhvmhd Santander Spain
Ozreskagcfgbzqojejtxvtjrfr Aalst Belgium
Mzqmiomsp Iayipidvxp Cndmmciq Swhbxjdo Skv z oxpv Warsaw Poland
Pzco Tmaqq Huaqcthb Uoqiuziqzprx Sabadell Spain
Cxjysn Hryrnedtrhh Uffoddtsxgphn Dq Dkddg Dijon France
Aqftxhz Ovlrdeobydl Ujkvoiaqnnpeu Syiqbp Siena Italy
Aziohtj Ookdjmgncme Ugvekjgasmupb Cnntzindrfsp Dlumd Shniqn E Dfskc Stwtrcm Dk Tabyym Turin Italy
Aqvgmbf Ohanbcfmgsb Uyvjynibhvqhl Ongayrto Rrgnhuq Foggia Italy
Fqfctxvgo Pxoj Lo Imfgrbshjmsuj Buvyhjevc Dlw Hopgyrgc Upmkngqdcdzgr Lv Par Madrid Spain
Hnjyqhcg Vztm dklipvtr Barcelona Spain
Sghmukjr dk Pblzhphpdch Dzm Lsxqdhp Drvpclvpc Sxulz Oradea Romania
Mnx Hphvcvfz Sa zlw Makow Podhalanski Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.04.2024
Czechia Czechia
Not recruiting
30.04.2024
France France
Not recruiting
30.04.2024
Germany Germany
Not recruiting
30.04.2024
Italy Italy
Not recruiting
30.04.2024
Poland Poland
Not recruiting
30.04.2024
Romania Romania
Not recruiting
30.04.2024
Spain Spain
Not recruiting
30.04.2024

Trial locations

Investigated drugs:

Axatilimab is a medication being studied for its potential to improve lung function in people with Idiopathic Pulmonary Fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial aims to determine if axatilimab can help reduce the progression of this scarring and improve breathing over a 26-week period.

Investigated diseases:

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The exact cause of this condition is unknown, and it primarily affects middle-aged and older adults. As the disease progresses, individuals may experience increasing difficulty in breathing, persistent dry cough, and fatigue. Over time, the scarring of lung tissue becomes more extensive, further impairing the ability to breathe deeply. This condition can significantly impact the quality of life, as it limits physical activity due to breathlessness. The progression of idiopathic pulmonary fibrosis varies among individuals, with some experiencing a rapid decline in lung function.

Trial ID:
2022-502954-15-00
Protocol code:
SNDX-6352-0506
NCT ID:
NCT06132256
Trial Phase:
Therapeutic exploratory (Phase II)

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