Study on the Effects of Itepekimab on Airway Inflammation in Former Smokers with Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called itepekimab on airway inflammation in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The treatment being tested, itepekimab, is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body that may contribute to inflammation in the airways.

The purpose of this study is to understand how itepekimab works in the body, particularly in reducing inflammation in the airways of people with COPD. The study is divided into two parts. In the first part, researchers will look at changes in gene activity in the airways of former smokers with COPD after receiving itepekimab. In the second part, they will confirm these findings in a similar group of participants. The medication is given as a solution for injection under the skin using a pre-filled syringe.

Participants in the study will receive either itepekimab or a placebo. The study will monitor changes in gene activity and other markers of inflammation in the airways over time. This research aims to provide insights into how itepekimab may help manage COPD by reducing airway inflammation, potentially leading to better treatment options for patients with this condition.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures.

The participant will be required to provide informed consent before any study-related activities begin.

2 screening and baseline assessments

The participant will undergo a series of assessments to confirm eligibility, including medical history review and physical examination.

Baseline measurements will be taken, including lung function tests and blood samples.

3 part A: treatment and monitoring

The participant will receive itepekimab through a subcutaneous injection. This is a solution for injection provided in a pre-filled syringe.

Regular monitoring will occur to assess the participant’s response to the treatment, including gene expression analysis from airway samples.

The participant will be observed for any side effects or adverse reactions to the treatment.

4 part B: validation and further monitoring

The participant will continue to receive itepekimab as in Part A.

Further assessments will be conducted to validate the findings from Part A, focusing on gene expression changes.

Ongoing monitoring for side effects and treatment responses will continue.

5 end of study assessments

At the end of the study, final assessments will be conducted to evaluate the overall impact of the treatment.

The participant will be informed about the study’s findings and any relevant follow-up care.

Who Can Join the Study?

Participant must be between 40 and 70 years old.
Must have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) for at least 1 year. COPD is a lung condition that makes it hard to breathe.
Must have a history of smoking at least 10 pack-years. This means smoking one pack a day for 10 years or the equivalent.
For former smokers: Must have quit smoking at least 6 months before the first study visit and intend to quit permanently.
For current smokers: Must be currently smoking and not planning to quit during the study period. Note: Current smokers are not eligible for Part A of the study.
Must have a history of chronic bronchitis, which is a long-term cough with mucus for at least 3 months in the year before the study, and other causes of cough have been ruled out.
Must have had at least one moderate or severe exacerbation of COPD in the last 5 years. An exacerbation is a worsening of symptoms. Moderate exacerbations need treatment with medications like steroids or antibiotics. Severe exacerbations require hospital care.
Must have been on stable COPD treatment for at least 3 months before the study. This includes using medications like inhalers regularly.
Must have received a COVID-19 vaccine at least 1 week before the first study visit.
Must have a Body Mass Index (BMI) of at least 18 kg/m². BMI is a measure of body fat based on height and weight.
Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for 20 weeks after the last dose of the study medication.

Who Cannot Join the Study?

Patients who are current smokers cannot participate. This means if you are still smoking, you are not eligible.
Patients with other serious lung diseases, besides Chronic Obstructive Pulmonary Disease (COPD), are not eligible. COPD is a long-term lung condition that makes it hard to breathe.
Patients who have had a recent lung infection or flare-up of their lung condition may not be eligible. A flare-up is when symptoms suddenly get worse.
Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that affect the heart, liver, or kidneys.
Patients who are pregnant or breastfeeding are not eligible to participate in the study.
Patients who have participated in another clinical trial recently may not be eligible. This is to ensure that the results of this study are not affected by other treatments.
Patients who are unable to follow the study procedures or attend the required visits cannot participate. This means if you cannot commit to the study schedule, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Aalborg University Hospital	Aalborg	Denmark
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Uwjbphbkobwg Mirfmko Cvrxepw Gbgzipkre	Groningen	The Netherlands
Hnurjtef Hsnshgkv	Hvidovre	Denmark
Hcgspf Hblrzxqt	Herlev	Denmark
Umifbwqdvx Os Almgsbj	Edegem	Belgium
Sppisuibkcuqqa Djq mbzv Syxbkpuci	Peine	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	20.05.2022
Denmark	Not recruiting	20.05.2022
Germany	Not recruiting	20.05.2022
The Netherlands	Not recruiting	20.05.2022

Trial locations

Investigated drugs:

Itepekimab

Itepekimab: This medication is an antibody that targets a specific protein involved in inflammation. In this trial, itepekimab is being studied to understand how it affects airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The goal is to see how it changes gene expression in the airways of former smokers with COPD.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, which is usually progressive. The disease often involves a combination of chronic bronchitis and emphysema, leading to symptoms such as coughing, mucus production, and shortness of breath. Over time, the airways and air sacs in the lungs lose their elastic quality, and the walls between many of the air sacs are destroyed. The walls of the airways become thick and inflamed, and the airways produce more mucus than usual, which can clog them. This condition is most commonly caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke.

Trial ID:

2024-512007-39-00

Protocol code:

PDY16967

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Itepekimab on Airway Inflammation in Former Smokers with Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?