The symptoms of bronchiectasis can be difficult to manage. Shortness of breath, chronic cough, chest discomfort, frequent respiratory infections, and fatigue can have a significant impact on people living with bronchiectasis. This can be difficult to deal with on a daily basis, even when taking different medications for the condition.

The aim of the ATMOS Study is to find potential future treatment options that may better address these unmet needs.

If you have bronchiectasis, you may be eligible to join the ATMOS Study. ATMOS is evaluating a study drug that is not available to the general public. We hope to learn how well it works to relieve bronchiectasis symptoms and what side effects participants may experience.

Participation in the ATMOS Study will last for at least 36 weeks (about 8 months). For some participants, the study may last up to 64 weeks (about 15 months). The ATMOS Study includes the following steps:

1. SCREENING: UP TO 4 WEEKSVisit the study center during which the study team will check if you can take part.
2. FIXED STUDY TREATMENT*: 24 WEEKSReturn to the study center for study tests. If the study is suitable, you will receive the study medication.
3. FLEXIBLE STUDY TREATMENT*: UP TO 28 WEEKS(after the Fixed Study Treatment Period)Depending on when you joined the study and whether enough information about the study drug has been collected, you may continue receiving the study medication.
4. FOLLOW-UP: 8 WEEKS AFTER STUDY MEDICATION ENDSFinal visit to the study center to check on your health and well-being after stopping the study medication.

*The study has both a Fixed and a Flexible Study Treatment Period. This is because researchers need to observe a certain number of bronchiectasis flare-ups to determine whether the study drug works better than placebo (a placebo looks like the study drug but has no medicinally active ingredients). As a result, people who join the study earlier may receive study medication longer than those who join later. However, everyone receives study medication for a minimum required amount of time during the Fixed Study Treatment Period.

If you think this study may be right for you, you will be assessed by the study team. Everything you need to know about the study will be explained to you. You will be given an Informed Consent Form (ICF), which provides further explanation.

If you agree to participate and sign the ICF, you will have a screening visit at the study center. If you meet all the study criteria, you can proceed in the study and receive the study medication.

The study drug is a type of drug called a biologic. A biologic works by focusing on a specific process in the body that causes illness. Instead of affecting the whole body, it targets the problem more directly.

The ATMOS Study is made up of two parts that run in parallel: the main study and a substudy:

• The main study will look at how well the study drug works to help relieve bronchiectasis symptoms and what side effects participants may experience.
• The substudy will look at what happens inside the lungs after receiving the study medication.
• Not all countries will take part in the substudy.
• The study duration and visit frequency is the same for everyone, but substudy participants will have a few more tests.

This study includes the use of a placebo, which looks like the study drug but has no medicinally active ingredients. Placebos are used to measure the effect of the study drug.

If you meet all the study criteria and participate in the study, you will receive either the study drug or placebo. You cannot choose whether you receive the study drug or placebo, and neither you nor the study team will know which one you are receiving. In an emergency, the study team can find out which one you received. You will have at least a 50% chance of receiving the study drug.

Both the study drug and placebo are given as a subcutaneous injection under the skin (usually on the lower stomach area, outside of the upper thigh, or upper arm).

During the study, you will be asked to visit the study center to have tests and receive the study drug or placebo on multiple occasions. The purpose of these tests is to check on your health and see how you are responding to the study medication.

Approximately half of the visits will last up to 2.5 hours, and the other half will take approximately 4.5 hours. Reasonable travel and meal expenses may be reimbursed, and travel assistance may be offered for you and anyone who needs to accompany you to the study visits.

The ATMOS Study will help researchers learn more about the study drug in people with bronchiectasis. The aim of the study is to find out more about the potential risks of the study drug (side effects) and whether it can improve symptoms of bronchiectasis. This study will also help researchers understand how the study drug acts in the body and how the body responds to it.

If you join the study, you will be asked to:

• Attend study visits at the study center, during which you will have different tests and assessments.
• Have your blood, urine, and mucus samples collected.
• Perform a simple breath test every morning and evening at home and record the results.
• Fill in a study diary at home.

You will be taking part in the ATMOS study for at least 36 weeks (8 months). For some participants, the study may last up to 64 weeks (about 15 months). The length of your participation will depend on when you join the study and when enough information about the study drug has been collected from everyone taking part.

Placebos are often compared with study drugs during clinical studies. Because a placebo does not contain any medicinally active ingredients, it should not have an effect on your condition.

Therefore, including a placebo group is the best way to help the study team:

• Better understand the effects (good or bad) of the study drug.
• Be as sure as possible that any effects (good or bad) are due to the study drug.

Using placebos in clinical studies is also often required by health authorities so that they can decide whether a study drug is well tolerated and works well enough to be made available to the wider public.

No, the study medication you receive will be decided at random by a computer. This process is called randomization. Neither you nor the study team will know which study medication you are receiving. This strategy, called blinding, ensures that results are handled fairly and not influenced by what you or the study team expect to happen.

During the study, you will continue taking your regular medication to manage your bronchiectasis. However, some bronchiectasis medications are not allowed before or during the study, so it may be necessary to switch these to a different type while in the study. As medication use can vary from person to person, the study team will go through all the medications you are taking, explain what you can continue, and let you know if any changes are required.

All studies involve risks and discomfort, including those from the study medication and study-related procedures. Some known risks and discomfort in this study include the following:

• Taking the study medication may cause side effects.
• In previous clinical studies of the study drug in participants with atopic dermatitis (eczema), the most common side effects were mild infections (influenza or cold-like symptoms such as runny nose and sore throat), headache, and redness where the injection is given.
• Where the injection is given, you may experience pain, swelling, itching, bleeding, bruising, and in some cases, blistering or infection.
• Blood draws may cause pain, bruising, or dizziness.
• The inflatable cuff used to measure your blood pressure may cause mild discomfort in your arm.
• The electrocardiogram (ECG) may cause discomfort from the sticky pads placed on your skin.
• The spirometry test to measure your lung function may make you feel dizzy, faint, shaky, sick, or tired for a short time afterwards.
• The high-resolution computed tomography (HRCT) scan will expose you to a certain amount of radiation. The study team will tell you more about this if you decide to participate in the study.

A more comprehensive list of known side effects of the study drug can be found in your Informed Consent Form, which will be given to you before you decide whether to join the study.

If side effects occur, the study team will monitor you and provide treatment to minimize any discomfort. While you are encouraged to tell your regular doctor that you are participating in this study, your study team will treat you for any side effects that may occur during your participation. You will also be covered by insurance against any study-related injury.

During the study, you will be asked to complete an electronic diary twice every day on a smartphone or an electronic tablet. If you don’t have a suitable device, the study team will provide one to use during the study. You can also complete the electronic diary via a web browser on a laptop or desktop computer. In the electronic diary, you will record your lung function and information about medications you take for bronchiectasis.

During the study, data will be collected on your lung function at regular intervals. To do this, the study team will provide you with a peak flow meter – a small, handheld device that measures how fast you can exhale air from your lungs. You will be asked to record this data in your electronic diary.

You will not have to pay for the study medication or any study-related tests or care. The cost of any other drugs or medical procedures outside of this study will not be covered. The study team will explain which activities are part of the study and which are part of your usual medical care.

You will not receive payment for your participation, but reasonable travel and meal expenses may be reimbursed. Travel assistance may be offered for you and anyone who needs to accompany you to the study visits.

Taking part in the ATMOS Study is completely voluntary. You are free to leave at any time and for any reason, without penalty. If you withdraw early from the study, you will be asked to visit the study center for an Early Discontinuation Visit to check on your health and well-being.

If you stop receiving study medication early and you agree, early discontinuation follow-up phone calls will be conducted every month until you reach your planned end of the study, or until the study itself ends. No study procedures will be performed. During these phone calls, you will be asked about any changes in your health and medication(s) you are or have been taking.

More information about this clinical study is available in the ClinicalTrials.gov database (English-language only).

ATMOS is a Greek word that means breath, vapor, or steam and is also part of the word “atmosphere”. It was chosen as the name for the ATMOS Study to signify the importance of air and breathing for people with bronchiectasis.

The ATMOS Study is sponsored by UCB, a global biopharma company based in Belgium.

All of your personal data collected for the study will be “coded” to remove any part of the personal data that could identify you. Using a code to identify you helps researchers keep your information confidential.

The overall results of this study will be available on ClinicalTrials.gov after all participants have left the study, all study data have been analyzed, and the final study report has been written. A summary of the results in plain language will be shared on the UCB website, but please note that it could take years until this is available. The study sponsor, UCB, may publish the results in an academic journal, but it will not include any information that can identify individual study participants.