Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
This research study is investigating new treatments for people who have moderate to severe atopic dermatitis, also known as eczema. Many people struggle with uncomfortable symptoms, and this study aims to find safer and more effective ways to help. The study will first focus on a specific new medicine called GHZ339. Participants will be split into groups, with some receiving the new medicine and others receiving a dummy treatment (placebo). This helps researchers understand if the new medicine is truly making a difference. The main goal is to see how well GHZ339 works and if it has any side effects, ultimately hoping to improve the lives of those affected by eczema.
At a glance
What is this study about?
This study is part of a larger research effort to find better treatments for moderate to severe atopic dermatitis, which is a type of eczema. Eczema can cause very itchy, red, and dry skin, and it can significantly impact a person's daily life. Doctors and scientists are always looking for new medicines that can effectively reduce these symptoms and improve quality of life for patients.
This particular study is designed to test a new medicine called GHZ339. To make sure the results are fair and accurate, some people in the study will receive GHZ339, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients. This helps researchers compare the effects of the new medicine against doing nothing, so they can tell if any improvements are due to the medicine itself.
The study is taking place in many different hospitals and clinics, and participants will be chosen randomly to receive either the active medicine or the placebo. This is a common and important step in developing new medicines, as it helps determine if they are both safe and effective before they can become widely available.
Key takeaways
- The study is testing a new medicine (GHZ339) for moderate to severe eczema.
- It aims to find out if the new medicine is safe and effective.
- Adults aged 18-100 with moderate to severe eczema may be eligible.
- Some participants will receive the new medicine, others a dummy treatment (placebo).
- Participation involves regular clinic visits for monitoring.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, you must be an adult aged 18 to 100 years old. You also need to have been diagnosed with atopic dermatitis (eczema) for at least a year, and your eczema must be considered moderate to severe by the study doctors. It's important that you understand what the study involves and are happy to give your permission to take part.
- Are you 18 to 100 years old?
- Have you been diagnosed with eczema (atopic dermatitis) for at least one year?
- Is your eczema considered moderate to severe?
- Do you feel you understand what the study involves and are willing to give consent?
- Do you have any other serious ongoing health conditions or infections?
- Are you free from any other active inflammatory skin diseases?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Details about what taking part involves will be fully explained if you are suitable for the study. Generally, you would receive either the new study medicine (GHZ339) or a dummy medicine (placebo). You would have regular visits to the study clinic for check-ups, where doctors and nurses would monitor your skin, take blood samples, and ask about your symptoms and how you are feeling. The total duration of your participation, including follow-up, will be clearly outlined to you during the consent process.
Potential risks and benefits
Locations (99)
- Novartis Investigative SiteBirmingham, United States· Recruiting
- Novartis Investigative SiteBirmingham, United States· Recruiting
- Novartis Investigative SiteFort Smith, United States· Recruiting
- Novartis Investigative SiteFountain Valley, United States· Recruiting
- Novartis Investigative SiteLos Angeles, United States· Recruiting
- Novartis Investigative SiteSacramento, United States· Recruiting
- Novartis Investigative SiteSanta Ana, United States· Recruiting
- Novartis Investigative SiteSanta Monica, United States· Recruiting
- Novartis Investigative SiteWashington D.C., United States· Recruiting
- Novartis Investigative SiteMiami, United States· Recruiting
- Novartis Investigative SiteAtlanta, United States· Recruiting
- Novartis Investigative SiteMacon, United States· Recruiting
+87 more sites — see the official record for the full list.
Common questions
What is atopic dermatitis?
Atopic dermatitis is a common type of eczema that causes intensely itchy, dry, and inflamed skin. It often starts in childhood and can sometimes continue into adulthood.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers see if the study medicine really makes a difference.
Will I know if I'm getting the new medicine or the placebo?
No, in this type of study (called 'double-blind'), neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps keep the results unbiased.
How long will the study last?
The exact length of time you would be in the study will be fully explained by the study team. Research studies can vary in duration, usually lasting several months.
What if I change my mind about participating?
You are free to withdraw from the study at any time, for any reason, without having to explain why. This will not affect your ordinary medical care.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.