Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2 trial of Gremubamab compared to placebo in participants with bronchiectasis and chronic Pseudomonas aeruginosa infection

This research study is called a 'Phase 2 trial'. This means it's an early study looking at how safe a new medicine called Gremubamab is, and if it could be helpful for treating specific health problems. In this case, the study is for adults who have a lung condition called bronchiectasis and also suffer from a persistent lung infection caused by bacteria known as Pseudomonas aeruginosa. The study will compare Gremubamab to a 'placebo', which is a dummy medicine that looks just like the real medicine but contains no active ingredients. This helps researchers understand if any improvements seen are truly due to the medicine. The main aim is to see how people feel and how their condition changes after 84 days, but researchers will also look at other things over a longer period.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

NHS Tayside, University Of Dundee

Enrolment target

Start

19 Sep 2023

bronchiectasis and chronic Pseudomonas aeruginosa infection

What is this study about?

This study is trying to find new ways to help people living with two health conditions: bronchiectasis and a chronic (long-term) infection in their lungs caused by bacteria called Pseudomonas aeruginosa. Bronchiectasis is a condition where the airways in your lungs become permanently widened and damaged, making it harder to clear mucus and leading to repeated infections.

The research is focused on a new potential medicine called Gremubamab. The main goal is to find out if this new medicine can make a difference for people with these conditions. To do this, the study will compare Gremubamab with a 'placebo'. A placebo is a substance that looks exactly like the new medicine but doesn't contain any active drug. Giving some participants the new medicine and others the placebo helps the researchers understand if any health changes are actually due to the medicine being tested, or if they happen for other reasons.

This is a 'Phase 2' study. This means it's an important early step in testing a new medicine. Researchers will be looking closely at how safe Gremubamab is and how well people tolerate it. They will also be gathering information to see if there are signs that the medicine could be effective in improving symptoms or reducing infections over time. This information will help decide if the medicine should be studied further in larger trials.

Key takeaways

It's a study for adults with bronchiectasis and a long-term 'Pseudomonas aeruginosa' lung infection.
The study is testing a new medicine, Gremubamab, against a dummy medicine (placebo).
It's a 'Phase 2' study, focusing on safety and early signs of how well the medicine works.
Participants will have regular check-ups and follow-up for several months.
The aim is to find better treatments for these challenging lung conditions.

Who may be eligible?

To join this study, participants must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.

More detailed health checks will be done by the study team to make sure it's safe for you to participate and that you meet all the specific requirements for the trial. These checks are important to ensure the study results are clear and meaningful for others with similar conditions.

For example, you would need to have a confirmed diagnosis of bronchiectasis and a persistent infection with Pseudomonas aeruginosa. The study team will explain all the specific health conditions or medications that might mean you couldn't join, as some medical situations could affect your safety or the study's results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have a diagnosis of bronchiectasis?
Do you currently have a chronic (long-term) lung infection with Pseudomonas aeruginosa?
Are you able to attend clinic visits regularly for several months?
Are you comfortable with potentially receiving a placebo (dummy medicine)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine, Gremubamab, or a placebo (a dummy medicine). Both the medicine and the placebo would be given as a 4ml injection. You wouldn't know whether you were receiving the real medicine or the placebo.

The main part of the study where the treatment is given and initial assessments are made lasts for 84 days. During this time, you would have several visits to the study clinic for check-ups, assessments, and possibly blood tests or other examinations. These visits would happen at specific times, such as on days 7, 14, 28, 56, and 84.

After the initial 84 days, there will be further follow-up visits, sometimes up to day 168 (about five and a half months) from when you started. These later visits are to make sure you're still well and to see how your health has changed over a longer period. The total duration of your involvement could be several months, including the treatment and follow-up periods.

Potential risks and benefits

Taking part in a clinical trial has potential benefits, such as contributing to medical knowledge that could help others in the future, and possibly receiving a new treatment that isn't yet widely available. However, there are also potential risks, including side effects from the new medicine, which might be mild or more serious, or the inconvenience of frequent clinic visits. There's also no guarantee that the new medicine will improve your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is bronchiectasis?

Bronchiectasis is a long-term lung condition where your airways become abnormally wide, making it harder to clear mucus and leading to infections.

What is Pseudomonas aeruginosa?

Pseudomonas aeruginosa is a common type of bacteria that can cause persistent lung infections, especially in people with conditions like bronchiectasis.

What does 'Phase 2' mean for a study?

Phase 2 means it's an early study to check if a new medicine is safe, well-tolerated, and shows signs of being helpful for a specific condition.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare effects.

How long will I be in the study?

Your involvement in the study could last up to about 168 days (about five and a half months), including treatment and follow-up.