RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate Solrikitug in Participants With COPD (ZION)

This research study, called ZION, is looking into a new medication called Solrikitug for people living with Chronic Obstructive Pulmonary Disease (COPD). The main goal is to understand if Solrikitug is safe, how different doses affect the body, and if it helps with COPD symptoms. Some participants will receive a low dose, some a high dose, and others a 'dummy' medicine (placebo), alongside their usual COPD treatments. This is a common way to test new medicines fairly. The study involves a 12-week treatment period where participants receive the medicine as injections, followed by a 16-week follow-up. About 171 people across many locations will take part to help scientists learn more about this potential new treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Uniquity One (UNI)

Enrolment target

171

Start

14 Aug 2024

Estimated completion

31 Oct 2026

COPD

What is this study about?

This study, known as ZION, is for people who have Chronic Obstructive Pulmonary Disease, or COPD. COPD is a long-term lung condition that makes it hard to breathe. Researchers are testing a new medicine called Solrikitug. They want to find out if it's safe for people with COPD, how well the body handles it, and if it might help improve symptoms when taken alongside your regular COPD medications.

To make sure the study is fair and the results are reliable, some participants will receive a low dose of Solrikitug, others a higher dose, and some will get a 'placebo.' A placebo looks just like the study medicine but contains no active drug. This helps researchers compare the effects of Solrikitug against no active treatment. Neither you nor your study doctor will know which treatment you are receiving, which is called 'double-blind.'

Around 171 people will be involved in this study across many hospitals and clinics. By taking part, you could be helping to advance our understanding of COPD and contribute to the development of new treatments that could benefit many people in the future.

Key takeaways

This study is testing a new medicine called Solrikitug for people with COPD.
It aims to find out if Solrikitug is safe and how it affects the body.
You might receive a low dose, a high dose, or a 'dummy' medicine (placebo).
Participation involves injections at a clinic over 12 weeks, plus 16 weeks of follow-up.
The study lasts about 7 months in total.
Your decision to join or leave the study won't affect your regular medical care.

Who may be eligible?

This study is looking for people aged between 40 and 75 years who have had a confirmed diagnosis of COPD for at least one year. You would also need to have certain lung function test results and experience some COPD symptoms in your daily life. Additionally, you should be using two or more regular inhaled medications for your COPD for at least three months before joining the study.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have ever had a serious allergic reaction to a similar type of medicine. Unfortunately, if you have other serious health problems, such as certain heart conditions, or other lung diseases that are not COPD, or have had major lung surgery recently, you might not be eligible.

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 between 40 and 75 years old?
Have you been diagnosed with COPD for at least one year?
Are you currently using two or more regular inhaled medications for your COPD?
Are you experiencing some COPD symptoms?
Are you NOT pregnant or breastfeeding?
Do you NOT have other serious health problems like certain heart conditions or other lung diseases?

Answer every question to see your result.

What does participation involve?

If you join the study, you would receive either the study medicine (Solrikitug) or a placebo through an injection under your skin, given at the study clinic. This would happen regularly over a 12-week period. During this time, and for another 16 weeks afterwards, you would have regular visits to the study clinic for check-ups. These visits will involve various assessments, such as physical exams, blood tests, and lung function tests, to track your health and how the treatment is affecting you. The total study duration, including the treatment and follow-up, would be about 28 weeks (seven months).

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from the close medical attention you receive and potentially from the new study medicine if it proves effective. However, there's also a chance you could experience side effects from the medicine, or the treatment might not help your condition. You'll receive all the detailed information about potential risks during the consent process. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (118)

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

University of Alabama at Birmingham Hospital
Verified postcode
Birmingham, United States· Recruiting
Syed Research Consultants
Verified postcode
Sheffield, United States· Recruiting
Phoenix Medical Group
Verified postcode
Peoria, United States· Recruiting
Epic Medical Research-Surprise
Verified postcode
Sun City, United States· Recruiting
Alliance for Multispecialty Research
Verified postcode
Tempe, United States· Recruiting
Novak Clinical Research
Verified postcode
Tucson, United States· Recruiting
Antelope Valley Clinical Trials
Verified postcode
Lancaster, United States· Recruiting
Ark Clinical Research - Ballinger
Verified postcode
Long Beach, United States· Recruiting
Downtown LA Research Center, Inc.
Verified postcode
Los Angeles, United States· Recruiting
Newport Native MD, Inc.
Verified postcode
Newport Beach, United States· Recruiting
OM Research
Verified postcode
Oxnard, United States· Recruiting
Prospective Research Innovations, Inc.
Verified postcode
Rancho Cucamonga, United States· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung disease that makes it hard to breathe, often causing coughing, wheezing, and shortness of breath.

What is Solrikitug?

Solrikitug is a new medicine being tested in this study. Researchers want to see if it's safe and effective for people with COPD.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the study medicine but doesn't contain any active drug. This helps scientists compare the effects of the actual medicine fairly.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study. Neither you nor your study doctor will know whether you are receiving Solrikitug or the placebo. This helps ensure the results are unbiased.

How long does the study last?

The study involves a 12-week period where you receive the treatment, followed by a 16-week follow-up period. So, the total time you would be involved is about 28 weeks (around 7 months).

How to find out more

Uniquity One Clinical Trials

clinicaltrials@uniquity.com 484-267-2500 Official trial record

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