RecruitingPHASE2INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD

This study is looking into a new medication called Verekitug for individuals living with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a common lung condition that makes it hard to breathe. The main goals of this research are to see if Verekitug helps improve COPD symptoms and how safe it is compared to a 'dummy' pill (placebo). Participants will be randomly assigned to receive one of two doses of Verekitug or the placebo, in addition to their current COPD medicines. The study will last for a long time, with treatment for over a year, to get a clear picture of the medicine's effects. It's a worldwide study involving many different medical centers.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Upstream Bio Inc.

Enrolment target

666

Start

02 Jul 2025

Estimated completion

01 Jul 2028

Chronic Obstructive Pulmonary Disease

What is this study about?

This research study is focused on finding new ways to help people with Chronic Obstructive Pulmonary Disease, or COPD. COPD is a long-term lung condition that inflames the airways and makes it increasingly difficult to breathe. This study is testing a new medication called Verekitug. We want to find out if Verekitug can make a real difference in how people with moderate to severe COPD feel and breathe, and importantly, if it is safe to use.

Researchers will be carefully checking how well Verekitug works compared to a 'dummy' pill, called a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps scientists understand if any changes a person experiences are truly due to the new medicine or other factors. Participants will continue to take their regular COPD medicines while taking part in this study.

The study involves many people around the world in different hospitals and clinics. By gathering information from a large group, we can get a clearer and more reliable understanding of Verekitug's effects. This kind of research is essential for developing new treatments and improving care for people living with COPD.

Key takeaways

This study tests a new medicine, Verekitug, for moderate to severe COPD.
It aims to check how well Verekitug works and if it's safe.
Participants will continue their usual COPD medicines.
The study involves either Verekitug or a 'dummy' pill (placebo).
Participation could last up to 2.5 years with regular clinic visits.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you would typically need to be an adult between 40 and 85 years old who has been diagnosed with COPD for over a year. You should also have a history of smoking for at least 10 "pack-years" (for example, smoking one pack a day for 10 years, or two packs a day for 5 years).

Your lung function tests would need to show certain results that indicate moderate to severe COPD. You should also be experiencing breathlessness that affects your daily activities. It's important that you have been taking your usual combination of three types of COPD inhalers (ICS, LABA, and LAMA) for at least three months, with stable doses for at least one month, and you need to be regularly using them.

There are also reasons why you might not be able to join. For example, if you've had a severe flare-up of your COPD or a chest infection recently (in the last 4 weeks). Also, if you use a lot of oxygen (more than 4 litres per minute, except for sleep apnoea), or if you've recently had other serious heart problems or conditions like asthma, your doctor might determine that this study isn't right for you. They will check for other specific health conditions or medications that might prevent you from taking part safely.

Quick self-check

Are you between 40 and 85 years old?
Have you been diagnosed with COPD for more than one year?
Do you have a history of smoking for at least 10 pack-years?
Do you get breathless with daily activities?
Have you been regularly using triple inhaler therapy (ICS/LABA/LAMA) for at least 3 months?
Have you *not* had a recent bad COPD flare-up or chest infection (last 4 weeks)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first go through a screening period, which lasts about 4 weeks. During this time, doctors will check if the study is suitable and safe for you. If you qualify, you'll be randomly assigned to one of three groups: two groups will receive different doses of Verekitug, and one group will receive a placebo (a dummy pill). You won't know which group you're in, and neither will your study doctor.

You will continue taking your usual COPD medicines alongside the study treatment. The treatment period itself will last for a long time, between 60 weeks (about 14 months) and up to 108 weeks (about 2 years). Throughout this period, you will have regular visits to the clinic for assessments and to check your health. After your last dose of the study medicine, there will be a follow-up period, with a final visit about 16 weeks later. The full study involvement could therefore last up to 2 years and 5 months.

Potential risks and benefits

Patients who take part in this study may experience potential benefits, such as improvements in their COPD symptoms or lung function, or new knowledge that could help future patients. However, as with any new medicine, there might be side effects or risks that we don't fully know about yet. Some side effects might be uncomfortable or even serious. The research team will monitor you closely for any problems. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (325)

Kern Research Inc.
Bakersfield, United States· Active not recruiting
PulmoCrit Associates
Encino, United States· Active not recruiting
Torrance Clinical Research Institute
Lomita, United States· Active not recruiting
Dream Team Clinical Research
Pomona, United States· Active not recruiting
Apex Clinical Research
San Diego, United States· Active not recruiting
Allianz Research Institute
Westminster, United States· Active not recruiting
Allianz Research Institute
Aurora, United States· Withdrawn
D&H Doral Research Center, LLC
Doral, United States· Active not recruiting
Qway Research, LLC
Hialeah, United States· Active not recruiting
Finlay Medical Research
Miami, United States· Active not recruiting
Research Institute of South Florida
Miami, United States· Active not recruiting
Florida Institute for Clinical Research,LLC
Orlando, United States· Active not recruiting

+313 more sites — see the official record for the full list.

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it hard for air to get in and out of your lungs, causing breathlessness and coughing.

What is a 'dummy pill' or placebo?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the new medicine is truly effective or if improvements are due to other reasons.

Will I stop taking my usual COPD medicines?

No, you will continue to take your regular COPD medications alongside the study treatment. Verekitug would be an addition to your current care.

How long does the study last?

The study involves a screening period of about 4 weeks, a treatment period of 60 to 108 weeks, and a follow-up period of 16 weeks after your last dose. So, your total involvement could be up to about 2.5 years.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time and for any reason. Your decision will not affect the quality of your medical care.

How to find out more

Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)

clinicaltrials@upstreambio.com 888-446-3130 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.