A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
This study is testing a new medicine called rocatinlimab for adults who have moderate to severe eczema, also known as atopic dermatitis. Eczema can cause itchy, dry, and inflamed skin. The study wants to find out if rocatinlimab, when used alongside regular eczema creams (like steroid creams or calcineurin inhibitors), is safe and effective in improving skin and reducing symptoms. Participants will be given either rocatinlimab or a dummy treatment (placebo) for 24 weeks. Researchers will closely monitor how well the skin clears up and if the eczema becomes less severe. They will specifically look at whether participants achieve clear or almost clear skin and if their eczema improves by 75% or more.
At a glance
What is this study about?
This research study is focused on a new medicine called rocatinlimab for people who have moderate to severe atopic dermatitis, which is a common type of eczema. Eczema can be very uncomfortable, causing red, itchy, and sometimes painful patches on the skin. Current treatments often include creams and ointments, but for some people, these aren't enough to get their eczema under control.
The main goal of this study is to see if rocatinlimab can help improve eczema symptoms more effectively than a dummy treatment (called a placebo) when both are used with standard eczema creams. Researchers will be looking at how well the skin clears up over 24 weeks, specifically if it becomes clear or almost clear. They will also measure if a person's eczema improves significantly, by at least 75%, during this time.
By carefully comparing the new medicine to a placebo, and studying things like itch and skin pain, the researchers hope to understand if rocatinlimab could offer a new and better way to manage chronic eczema for adults. This information is important for potentially developing new treatments that could help many people struggling with this condition.
Key takeaways
- This study evaluates a new treatment, rocatinlimab, for moderate to severe eczema.
- It aims to see if the medicine, combined with regular creams, can clear skin and reduce symptoms.
- Participants will receive either rocatinlimab or a dummy treatment for 24 weeks.
- The study wants to find out if skin becomes clear/almost clear, or improves by 75%.
- It's a Phase 3 study, meaning it's in a larger trial stage to confirm effectiveness and safety.
Who may be eligible?
This study is for adults aged 18 and over. Both men and women can take part.
To be considered, you must have moderate to severe atopic dermatitis, which means your eczema is severe enough to significantly impact your everyday life and may not be well-controlled with your current treatments. Specific details about the severity of your eczema will be checked by the study doctors.
The study team will review your medical history and current health to make sure it's safe for you to participate and that the study is a good fit for your condition. There will be other detailed criteria that the doctors will look at, but generally, you need to be an adult with moderate to severe eczema.
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 18 years old or older?
- Do you have moderate to severe atopic dermatitis (eczema)?
- Are you currently using topical (on-the-skin) eczema creams?
- Are you able to attend regular clinic visits for about 24 weeks?
What does participation involve?
If you decide to join this study, you will be in it for about 24 weeks. You will receive either the new medicine, rocatinlimab, or a dummy treatment (placebo), alongside your usual eczema creams. Neither you nor your study doctor will know which treatment you are getting until the study ends. This helps to make sure the results are as fair and accurate as possible.
You will have regular visits to the study clinic where doctors and nurses will check your skin, ask about your symptoms like itching and pain, and monitor your general health. You might have blood tests or other assessments during these visits. The study team will provide all the necessary medication and instructions. After the main 24-week treatment period, there might be follow-up visits to see how you are doing.
Potential risks and benefits
Locations (14)
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedSlovakia
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedSlovenia
- —UnverifiedGreece
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedBelgium
Common questions
What is atopic dermatitis?
Atopic dermatitis is a common type of eczema that causes dry, itchy, and inflamed skin. It can affect people of all ages but often starts in childhood.
What is a 'Phase 3' study?
Phase 3 means this medicine has already been tested in smaller groups of people, and now it's being tested in a larger group to confirm if it works well and is safe.
What is rocatinlimab?
Rocatinlimab is the name of the new medicine being tested in this study. It aims to help calm down the inflammation that causes eczema.
Will I still use my regular eczema creams?
Yes, in this study, the new medicine (or placebo) is used in combination with your usual eczema creams, such as topical corticosteroids or calcineurin inhibitors.
What is a placebo?
A placebo is a dummy treatment that looks exactly like the study medicine but contains no active ingredients. It helps researchers compare how well the new medicine works.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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