A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Ignite)
This research study is looking at a new medicine called rocatinlimab (AMG 451) for adults who have moderate to severe eczema, also known as atopic dermatitis. Eczema can cause very itchy, red, and dry skin. The study will last 24 weeks and will compare rocatinlimab to a 'placebo' – a dummy treatment that looks just like the real medicine but contains no active drug. This is a "double-blind" study, meaning neither the participants nor their doctors will know who is getting the real medicine and who is getting the placebo. The main goals are to see if rocatinlimab effectively clears or nearly clears the skin and significantly reduces the amount of eczema, as well as if it's safe and well-tolerated.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research study to test new treatments in people. Here, doctors and researchers are testing a new medicine called rocatinlimab for adults who have moderate to severe atopic dermatitis, which is a type of eczema. Eczema can be very uncomfortable, causing itchy, red, and dry skin. The aim of this study is to find out if rocatinlimab can help improve these symptoms more effectively than a dummy treatment, and importantly, if it is safe for people to use.
Participants in the study will be given either rocatinlimab or a 'placebo' for 24 weeks. A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps researchers understand whether any improvements are truly due to the new medicine or other factors. Neither you nor your study doctor will know whether you are receiving the active medicine or the placebo, which helps make the study as fair and accurate as possible. This is called a 'double-blind' study.
The main things the researchers will be looking for are how well the medicine helps clear up your skin or make it almost clear, and how much it reduces the overall area and severity of your eczema. They will also be closely watching to see if the medicine causes any unwanted side effects and how your body reacts to it over the 24-week period.
Key takeaways
- This study is testing a new medicine for moderate to severe eczema.
- It lasts 24 weeks and compares the new medicine to a dummy treatment (placebo).
- Neither you nor your doctor will know if you're getting the active medicine.
- The goal is to see if the medicine helps clear skin, reduces eczema, and is safe.
- Regular visits and assessments will be part of taking part.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you must have moderate to severe atopic dermatitis (eczema). This means your eczema impacts your daily life significantly, and its signs and symptoms meet specific levels that the study doctors will assess. There will be other health requirements and conditions that might prevent you from joining, which the study team will discuss with you in detail.
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 eczema (atopic dermatitis)?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive a dummy treatment (placebo) instead of the active medicine?
What does participation involve?
If you decide to take part in this study, you will first go through a screening process to make sure it's suitable for you. This will involve health checks and tests. Once accepted, you would receive either the study medicine (rocatinlimab) or a placebo, likely in the form of injections, for 24 weeks. You would have regular visits to the study clinic during this time. These visits will involve check-ups, blood tests, and assessments of your eczema symptoms, such as how clear your skin is and how much it itches or causes pain. The doctors will also carefully monitor any side effects you might experience. After the 24 weeks of treatment, there will likely be follow-up visits to monitor your health.
Potential risks and benefits
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Common questions
What is rocatinlimab?
Rocatinlimab is a new medicine being tested for people with eczema (atopic dermatitis). This study is trying to understand if it can help improve skin symptoms.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but does not contain any active drug. It helps researchers compare the new medicine's effects accurately.
What does 'double-blind' mean?
It means that neither you, nor your study doctor, will know whether you are getting the active medicine or the placebo. This helps prevent any bias in the study results.
How long will the study last for me?
The main treatment part of the study will last for 24 weeks, which is about 6 months. There may be follow-up appointments after this.
Will I have to pay to be in the study?
No, you should not have to pay to participate in the study. All study-related treatments and assessments are usually provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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