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Study on the Effects of ARO-RAGE (ADS-015) for Patients with Inflammatory Lung Disease

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called ARO-RAGE for people with Inflammatory Lung Disease, which includes conditions like asthma. The treatment involves an inhalation solution containing a substance known as ADS-015, which is a specially designed molecule that targets specific cells in the lungs. The study will also use a placebo, which is a solution that does not contain the active treatment, to compare the effects.

The purpose of the study is to assess the safety and tolerability of ARO-RAGE in both healthy individuals and patients with inflammatory lung conditions. Participants will receive the treatment through a device called the Pari eFlow nebulizer, which helps deliver the medication directly to the lungs. The study will monitor participants over a period of time to observe any side effects and changes in lung function.

Throughout the study, researchers will collect data on how the treatment affects lung health, including measurements like forced expiratory volume (FEV1) and forced vital capacity (FVC), which are indicators of how well the lungs are working. The study aims to provide valuable information on the potential benefits and safety of ARO-RAGE for people with inflammatory lung diseases.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and specific tests such as a 12-lead ECG and chest x-ray to ensure no significant respiratory diseases are present.
Participants must have a stable asthma treatment regimen and meet specific health criteria, including a body mass index (BMI) between 18.0 and 35.0 kg/m² and a nonsmoking status.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. These include lung function tests such as forced expiratory volume (FEV1) and forced vital capacity (FVC), as well as blood tests to measure eosinophil count and other relevant parameters.
Step 3
Medication administration
Participants receive the study medication, ARO-RAGE inhalation solution, administered via inhalation. The dosage and frequency are determined based on the study protocol and participant group.
The medication is administered under supervision to monitor any immediate reactions or side effects.
Step 4
Ongoing monitoring
Throughout the study, participants attend regular visits for monitoring. This includes repeated lung function tests, blood tests, and assessments of any side effects or adverse events.
Participants are required to maintain their regular asthma treatment regimen unless advised otherwise by the study team.
Step 5
Final assessment
At the end of the study, a final assessment is conducted. This includes a comprehensive review of all collected data, including changes in lung function and any side effects experienced.
Participants may be required to continue using effective contraception for a specified period after the study concludes.

Who can join the trial?

18 criteria

Must be a male or a nonpregnant, nonlactating female volunteer.
Must be between 18 to 65 years old, depending on the specific group.
Must have a doctor-diagnosed asthma that has been confirmed and documented for at least 12 months before the screening.
Must have mild or moderate asthma, as defined by specific guidelines, for at least 6 months before the screening.
Must have a prebronchodilator ppFEV1 (a lung function test) of at least 40% or 70% at screening, depending on the group.
Must have a blood eosinophil count (a type of white blood cell) of at least 200 cells/µL at screening.
Must be on a stable dose of asthma controller medications for at least 4 weeks or 28 days before screening, depending on the group.
If receiving allergen-specific immunotherapy, must be on a stable maintenance dose for at least 3 months before the first dose.
Must have a chest x-ray at screening that shows no significant alternative respiratory disease.
Must be able and willing to provide written informed consent before any study-specific procedures.
Must have a Body Mass Index (BMI) between 18.0 and 35.0 kg/m² at screening.
Must have a 12-lead ECG (a heart test) at screening with no abnormalities that may compromise safety in the study.
Must be a nonsmoker, defined as someone who has not smoked a cigarette for at least 6 months, with current nonsmoking status confirmed by a urine test at screening. Previous smoking history must be less than 10 pack-years.
Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Must not donate sperm or eggs during this time.
Must be able and willing to comply with all study assessments and adhere to the protocol schedule.
Must be able to produce an induced sputum sample at screening that meets the criteria of acceptable quality.
If on allergen-specific immunotherapy, patients must be on a stable maintenance dose for at least 3 months prior to first dose.
Must have a FeNO (a test measuring airway inflammation) of at least 35 parts per billion at each visit during screening.

Who cannot join the trial?

13 criteria

Individuals with any other serious health conditions that could interfere with the study.
People who are currently participating in another clinical trial.
Pregnant or breastfeeding women.
Individuals with a history of allergic reactions to similar medications.
People who have had a recent major surgery.
Individuals with a history of drug or alcohol abuse.
People who are unable to follow the study procedures or instructions.
Individuals with certain heart conditions.
People with uncontrolled high blood pressure.
Individuals with severe liver or kidney disease.
People with a history of certain mental health disorders.
Individuals who have received a live vaccine within the last 30 days.
People with a history of certain lung diseases, other than the one being studied.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Verified
Medicome Sp. z o.o.
Oświęcim, Poland

Trial locations

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Investigated drugs

ARO-RAGE is an inhalation solution being studied for its effects on healthy individuals and patients with inflammatory lung disease. The main goal of the trial is to evaluate how safe and tolerable this medication is when used by these groups.

Ads-015

What is already known about the treatment

ARO-RAGE – ARO-RAGE is an inhalation solution currently being studied in clinical trials for its effects on inflammatory lung disease. It is administered through inhalation, allowing the medication to directly target the lungs. The main therapeutic indication is to treat inflammatory lung conditions by reducing inflammation and improving lung function. At the molecular level, ARO-RAGE works by interfering with specific pathways that lead to inflammation in the lungs. It is classified pharmacologically as an anti-inflammatory agent. The current status in medical literature is that it is in the early phases of clinical trials, focusing on safety and tolerability in both healthy individuals and patients with lung disease.

Investigated diseases

Inflammatory Lung Disease – This condition involves inflammation of the lung tissues, which can lead to symptoms such as coughing, shortness of breath, and chest discomfort. The inflammation can be caused by various factors, including infections, environmental pollutants, or autoimmune reactions. Over time, the inflammation may cause damage to the lung tissues, potentially affecting the ability to breathe efficiently. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more severe respiratory issues. The condition can affect people of all ages and may require ongoing monitoring to manage symptoms effectively.