Study on Efzofitimod for Treating Pulmonary Sarcoidosis in Patients

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What is this study about?

This clinical trial is focused on studying pulmonary sarcoidosis, a condition where clusters of inflammatory cells form in the lungs, affecting breathing and lung function. The study will evaluate the effectiveness and safety of a treatment called Efzofitimod, which is administered through an injection into the veins. This treatment is being compared to a placebo to determine its impact on the disease.

The purpose of the study is to assess how well Efzofitimod works in treating patients with pulmonary sarcoidosis. Participants in the study will receive either the treatment or a placebo over a period of time. The study will monitor changes in the participants’ condition, including any improvements in lung function and overall health. The treatment period is designed to last up to 48 weeks, during which participants will be closely observed by medical professionals.

Throughout the study, participants will undergo regular check-ups to track their progress and any side effects. The goal is to gather information on how Efzofitimod can help manage symptoms of pulmonary sarcoidosis and improve the quality of life for those affected by this condition. This research aims to provide valuable insights into new treatment options for patients with this lung disease.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the trial.

You must meet specific criteria, such as being between 18 and 75 years old, having a confirmed diagnosis of pulmonary sarcoidosis for at least 6 months, and being on a stable dose of oral corticosteroids (OCS) for at least 3 months.

2 initial assessments

Before starting the treatment, initial assessments will be conducted. These include a review of your medical history, a physical examination, and tests to confirm your eligibility.

If you are a female of childbearing potential, a pregnancy test will be conducted to ensure you are not pregnant.

3 treatment phase

During the treatment phase, you will receive the study medication, efzofitimod, through an intravenous injection. This means the medication will be administered directly into your vein.

The study is double-blind, meaning neither you nor the study team will know if you are receiving efzofitimod or a placebo. This is to ensure unbiased results.

4 regular follow-ups

You will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical exams, blood tests, and assessments of your lung function.

Your daily dose of oral corticosteroids may be adjusted based on your response to the treatment.

5 end of treatment

At the end of the treatment period, final assessments will be conducted to evaluate the effects of the study medication on your condition.

You will be asked to provide feedback on your experience during the trial.

6 post-study follow-up

After completing the study, there will be a follow-up period to monitor your health and any long-term effects of the treatment.

You will be informed about the overall results of the study once they are available.

Who Can Join the Study?

Men and women aged 18 to 75 years can participate.
Must have a confirmed diagnosis of pulmonary sarcoidosis for at least 6 months. This means the disease has been proven by a tissue biopsy and there is evidence of lung involvement from past X-rays or scans.
Must have symptoms of pulmonary sarcoidosis, shown by:
- A score of at least 1 on the Modified Medical Research Council (MRC) Dyspnea Scale, which measures breathlessness.
- A KSQ-Lung score of 70 or less, which assesses lung health.
Must be taking oral corticosteroids (OCS) for at least 3 months, with a starting dose between 7.5 mg and 25 mg per day. OCS are medications used to reduce inflammation.
Body weight must be at least 40 kg (about 88 pounds) and less than 160 kg (about 352 pounds).
If a woman can have children, she must:
- Not be pregnant or breastfeeding, and have a negative pregnancy test before starting the study.
- Agree to use effective birth control methods from the start of the study until 8 weeks after the last dose of the study drug.
Must provide written consent to participate in the study.
Must agree to follow all study procedures and requirements.

Who Cannot Join the Study?

Patients who do not have pulmonary sarcoidosis cannot participate. Pulmonary sarcoidosis is a condition that affects the lungs.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who belong to a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Hôpital Avicenne	Bobigny	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Multimedica S.p.A.	Milan	Italy
Ospedale “Morgagni – Pierantoni” di Forlì	Forli'	Italy
Azqusetmxl Pmdtesxw Hgnzjlxs Dx Phhbr	Paris	France
Ahldfrt Oghufvvwrfk Umcbnfiqpkboa Sztdjv	Siena	Italy
Autkglija Ulq	Amsterdam	The Netherlands
Hbygfpfg Umfoignarvbxd Dw Lc Pwvuxeis	Madrid	Spain
Hgcyvjyb Udsgxigabtxpb Mmtovdb Db Vevdxgageh	Santander	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.06.2023
Germany	Not recruiting	15.06.2023
Italy	Not recruiting	15.06.2023
Spain	Not recruiting	15.06.2023
The Netherlands	Not recruiting	15.06.2023

Trial locations

Investigated drugs:

Efzofitimod

Efzofitimod is a medication being tested to see if it can help people with pulmonary sarcoidosis, a condition where small clusters of inflammatory cells called granulomas form in the lungs. This medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The goal of using efzofitimod in this study is to determine if it can reduce the symptoms of pulmonary sarcoidosis and improve lung function, making it easier for patients to breathe and carry out daily activities. The study is also looking at the safety of efzofitimod to ensure it does not cause harmful side effects for the patients.

Investigated diseases:

Pulmonary sarcoidosis

Pulmonary Sarcoidosis – Pulmonary sarcoidosis is a condition characterized by the growth of tiny collections of inflammatory cells, called granulomas, in the lungs. These granulomas can cause the lung tissue to become inflamed and may lead to scarring over time. The disease often begins with symptoms such as a persistent dry cough, shortness of breath, and chest pain. As the condition progresses, it can lead to more severe respiratory issues and reduced lung function. The exact cause of pulmonary sarcoidosis is unknown, but it is believed to involve an abnormal immune response. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others developing more significant lung impairment.

Trial ID:

2023-506039-13-00

Protocol code:

ATYR1923-C-004

NCT ID:

NCT05415137

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Efzofitimod for Treating Pulmonary Sarcoidosis in Patients

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