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RecruitingPHASE2INTERVENTIONAL

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis

This research is looking into a new medicine called Galvokimig for adults who have a form of chronic eczema known as atopic dermatitis. Specifically, we're focusing on people whose eczema is moderate to severe. The main goal is to figure out the right amount (dose) of Galvokimig that works best. We'll also be carefully checking how effective the medicine is at improving eczema symptoms and making sure it's safe to use. To do this, some participants will receive Galvokimig, while others will get a placebo, which is an inactive substance, to compare the results fairly. This information will help us understand if Galvokimig could be a helpful new treatment option in the future.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
UCB Biopharma SRL
Enrolment target
160
Start
29 Dec 2025
Estimated completion
06 Mar 2028

What is this study about?

This study is about a new medicine called Galvokimig, and it's for adults who have a common skin condition called atopic dermatitis, also known as eczema. Many people experience eczema, which can cause dry, itchy, red skin. For some, the eczema is more serious, causing significant discomfort and affecting daily life. The new medicine, Galvokimig, is being tested as a potential way to help manage these more severe cases.

The main purpose of this research is to understand how well different strengths (doses) of Galvokimig work. We want to find out which dose is most effective at reducing the symptoms of eczema, like itching and skin dryness, while also being safe for people to use. To make sure we get clear answers, some participants will receive the actual medicine, Galvokimig, while others will receive a 'placebo'. A placebo looks exactly like the medicine but doesn't contain any active ingredients. This helps doctors see if the improvements are really due to Galvokimig or just other factors.

By taking part, you would be helping medical researchers learn more about atopic dermatitis and potential new treatments. This kind of study is a crucial step in developing new medicines. The information we gather will help us understand if Galvokimig could someday be a new option for people struggling with moderate to severe eczema.

Key takeaways

  • This study is for adults (18+) with moderate to severe eczema (atopic dermatitis).
  • It aims to find the most effective and safest dose of a new medicine called Galvokimig.
  • Participants will receive either Galvokimig or a dummy medicine (placebo).
  • Regular clinic visits and health checks will be part of the study.
  • Participation involves close medical monitoring, but there's no guarantee of benefit.
  • You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been living with chronic eczema (atopic dermatitis) for at least one year. Your eczema needs to be considered moderate to severe by the study doctor. This means it affects a significant area of your body, causes noticeable itchiness, and has been given a particular severity score by the doctor.

You might be a good fit if your current eczema treatments, like creams or ointments, haven't worked well enough, or if those treatments cause problems for you and your doctor thinks you should consider stronger medicines. You also need to be generally healthy apart from your eczema.

However, there are some reasons why you might not be able to join. For example, if you have other serious health conditions, especially certain bowel diseases, or if you've had frequent serious infections recently, you wouldn't be able to take part. Also, if you have other skin conditions that might make it hard to tell if the eczema is improving, you wouldn't 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.

  1. Are you 18 years old or older?
  2. Have you had chronic eczema (atopic dermatitis) for at least one year?
  3. Do you have moderate to severe eczema that affects a noticeable area of your body and causes significant itch?
  4. Have your current eczema creams or usual treatments not worked well enough for you?
  5. Are you generally healthy, without other serious medical conditions like certain bowel diseases or frequent infections?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new medicine, Galvokimig, or a placebo, which is a dummy medicine. You wouldn't know which one you're getting. You would have regular visits to the study clinic where doctors and nurses would check your eczema, measure your symptoms like itching and skin redness, and take blood samples. They would also do general health checks and ask questions about how you're feeling to monitor your safety. The total length of your participation in the study and the number of visits would be explained in detail by the study team, but these types of studies often involve several months of regular appointments, followed by a period where your health is monitored.

Potential risks and benefits

Taking part in a clinical trial could bring some potential benefits. You would receive close medical monitoring and access to a new investigational medicine that might improve your eczema symptoms. However, there are also potential risks, as Galvokimig is an experimental drug whose full effects aren't yet known. You might experience side effects, and there's no guarantee that the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (62)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Atd002 52021
    Verified postcode
    Oceanside, United States· Recruiting
  • Atd002 52008
    Verified postcode
    Santa Monica, United States· Recruiting
  • Atd002 52013
    Verified postcode
    Boca Raton, United States· Recruiting
  • Atd002 52007
    Verified postcode
    Coral Gables, United States· Recruiting
  • Atd002 52003
    Verified postcode
    Miami, United States· Recruiting
  • Atd002 52015
    Verified postcode
    Savannah, United States· Recruiting
  • Atd002 52017
    Verified postcode
    Chicago, United States· Recruiting
  • Atd002 52018
    Verified postcode
    Wheaton, United States· Recruiting
  • Atd002 52012
    Verified postcode
    New Albany, United States· Recruiting
  • Atd002 52014
    Verified postcode
    Bowling Green, United States· Recruiting
  • Atd002 52001
    Verified postcode
    Troy, United States· Recruiting
  • Atd002 52009
    Verified postcode
    Troy, United States· Recruiting

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common, long-lasting skin condition also known as eczema. It causes itchy, dry, inflamed skin, and it can sometimes flare up badly.

What is a 'placebo'?

A placebo is a substance that looks just like the real medicine but doesn't have any active ingredients. It's used in studies to compare against the new medicine to see if the real drug is truly effective.

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

No, during the main part of the study, neither you nor the study doctors will know if you're receiving Galvokimig or the placebo. This helps ensure unbiased results.

Can I continue using my normal eczema creams?

This would depend on the study rules. You would need to discuss all your current medications, including creams, with the study doctor to see what is allowed or needs to be stopped.

What happens if my eczema gets worse during the study?

Your health and safety are the top priority. If your eczema worsens or you experience any concerning symptoms, the study team would provide medical care and decide if you need to stop the study treatment.

How to find out more

UCB Cares

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharm…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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