Study on the Effects and Safety of Namilumab for Patients with Chronic Lung Sarcoidosis

What is this study about?

This clinical trial is focused on studying a lung condition called chronic pulmonary sarcoidosis. This disease involves inflammation in the lungs, which can cause breathing difficulties and other health issues. The study is testing a treatment called Namilumab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific parts of the immune system to help reduce inflammation.

The purpose of the study is to evaluate how effective Namilumab is in reducing the need for additional treatments when the symptoms of sarcoidosis worsen. Participants in the study will receive either Namilumab or a placebo, which is a substance with no active medication. The study will follow participants over a period of time to monitor their response to the treatment and any changes in their condition.

Throughout the study, participants will receive regular check-ups to assess their lung function and overall health. This will include physical examinations, vital sign measurements, and other routine tests to ensure safety and track the effectiveness of the treatment. The study aims to provide valuable information on whether Namilumab can be a beneficial treatment option for those living with chronic pulmonary sarcoidosis.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the namilumab treatment or a placebo. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

The participant must meet specific criteria, such as being 18 years or older, having a documented history of sarcoidosis for at least six months, and having completed the primary series of COVID-19 vaccinations at least two weeks prior to randomization.

2 treatment administration

The treatment involves a subcutaneous injection of either namilumab or a placebo. The exact dosage and frequency of administration will be determined by the study protocol.

Participants will receive these injections over a specified period, with regular monitoring to assess the treatment’s effects.

3 monitoring and assessment

Throughout the study, participants will undergo various assessments to monitor their health and the treatment’s impact. This includes physical examinations, vital signs checks, electrocardiograms (ECGs), and laboratory tests.

The primary goal is to evaluate the effect of namilumab on the need for additional treatment due to worsening sarcoidosis.

4 evaluation of outcomes

The study will measure several outcomes, such as the proportion of participants needing additional treatment during the double-blind period and changes in lung function and quality of life scores.

Safety and tolerability of the treatment will also be assessed, with attention to any adverse effects experienced by participants.

5 open-label extension

After the initial double-blind phase, participants may enter an open-label extension where all will receive namilumab. This phase allows further evaluation of the treatment’s long-term effects.

Participants will continue to be monitored closely to ensure their safety and to gather additional data on the treatment’s efficacy.

Who Can Join the Study?

Must be a male or female who is 18 years or older.
Must be able and willing to provide written informed consent. This means you agree to follow the study rules and understand what the study involves.
Must have a history of sarcoidosis for 6 months or more, with proof in your medical records.
Must show signs of sarcoidosis through:
- A HRCT scan that matches Pulmonary Sarcoidosis.
- A score of 2 or more on the Medical Research Council Dyspnea scale, which measures breathing difficulty.
- One or more of the following:
  - A FDG-PET scan showing signs of pulmonary sarcoidosis with a SUVmax of 3 or more.
  - Recent worsening of sarcoidosis symptoms.
  - Recent increase in lung problems when reducing oral corticosteroids (OCS) or immunosuppressive therapies (ISTs).
Must have a Body Mass Index (BMI) of 40 kg/m² or less at the time of screening. BMI is a measure of body fat based on height and weight.
Must have completed the primary series of COVID-19 vaccinations at least 2 weeks before starting the study.

Who Cannot Join the Study?

Patients who have other serious health conditions that could interfere with the study.
Patients who are currently taking medications that might affect the study results.
Patients who have had a recent surgery or medical procedure.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar treatments.
Patients who are unable to follow the study procedures or attend study visits.
Patients who have participated in another clinical trial recently.
Patients who have a history of substance abuse or alcohol dependency.
Patients who have an active infection or illness that requires treatment.
Patients who have been diagnosed with a mental health condition that might affect their ability to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Cvhjrtvfs Uysbiqsfsdpwwy Spqpjqvil	Woluwe-Saint-Lambert	Belgium
Lxpgf Uhbmioagpcyx Mxzfflr Ctrykgj (rejcz	Leiden	The Netherlands
Hpukilv Bzgygn Czzsgygcxiupss Axrxc	Paris	France
Eveizni Uneanehkscyq Mbzdhqb Cdyfhce Rouazqomt (pwfbstb Mdm	Rotterdam	The Netherlands
Uud Mgzbihqiczbb	Yvoir	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.12.2022
France	Not recruiting	12.12.2022
Germany	Not recruiting	12.12.2022
The Netherlands	Not recruiting	12.12.2022

Trial locations

Investigated drugs:

Namilumab

Namilumab is a medication being studied for its potential to help people with chronic pulmonary sarcoidosis. This condition affects the lungs, and the study aims to see if namilumab can reduce the need for additional treatments when the disease gets worse.

Chronic Pulmonary Sarcoidosis – This is a condition characterized by the growth of tiny collections of inflammatory cells in the lungs. These clusters, known as granulomas, can affect how the lungs function. Over time, the granulomas may lead to scarring and stiffness in the lung tissue, which can make breathing difficult. The disease can progress slowly, with symptoms that may include a persistent cough, shortness of breath, and chest pain. The exact cause of sarcoidosis is unknown, but it is believed to involve an abnormal immune response. The condition can vary greatly in severity and may remain stable or worsen over time.

Trial ID:

2024-511115-25-00

Protocol code:

KIN-1902-2001

NCT ID:

NCT05314517

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of Namilumab for Patients with Chronic Lung Sarcoidosis

What is this study about?

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