A Phase 3, Randomized, 24-week, 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-Horizon)
This 24-week study is testing a new medicine called Rocatinlimab for adults who have moderate to severe eczema, also known as atopic dermatitis. Half of the participants will receive Rocatinlimab, and the other half will receive a dummy medicine (placebo). Neither the participants nor their doctors will know who is getting which treatment until the study ends. We want to find out how well Rocatinlimab works to clear up skin and reduce symptoms like itching, and if it's safe and causes any side effects. This is a "Phase 3" study, meaning it's one of the final steps before a medicine might be approved for wider use.
At a glance
What is this study about?
This research study is about a new medicine called Rocatinlimab for adults who have moderate to severe eczema (also known as atopic dermatitis). Eczema is a common skin condition that causes patches of skin to become itchy, red, dry, and cracked. For some people, it can be very uncomfortable and affect their daily lives.
The main aim of this study is to see if Rocatinlimab can help improve eczema symptoms, such as making the skin clearer or significantly better, after 24 weeks of treatment. We also want to check if the medicine is safe to use and if it causes any unwanted side effects. To do this, we will compare Rocatinlimab to a dummy medicine, called a placebo. This helps us understand if any improvements are due to the new medicine itself, rather than other factors.
Over the 24 weeks, we'll be carefully checking skin improvements, how much itching participants experience, and if their quality of life improves. We'll also look at things like skin pain and how clear their face and hands are. This detailed information will help researchers understand if Rocatinlimab could be a helpful new treatment option for people with eczema.
Key takeaways
- This study is testing a new medicine called Rocatinlimab for moderate to severe eczema.
- It lasts 24 weeks and compares the new medicine to a dummy pill (placebo).
- Doctors will check if your skin clears up or gets much better, and if itching improves.
- The study also looks at the safety of Rocatinlimab and any side effects.
- You won't know if you're getting the medicine or the placebo.
- It aims to find out if Rocatinlimab could be a future treatment option.
Who may be eligible?
To be considered for this study, you must be an adult, aged 18 years or older. This study is open to both men and women.
You should have eczema that is considered moderate to severe by the study doctors. They will use specific ways to measure the seriousness of your eczema to make sure you fit the study's requirements.
There might be other health conditions or medicines that would prevent you from joining, so the study team will ask you about your full medical history to confirm if this study is right for you.
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 generally willing to attend regular clinic appointments for 24 weeks?
- Are you comfortable with the possibility of receiving a dummy medicine (placebo)?
What does participation involve?
If you decide to take part in this study, you will be in it for 24 weeks. During this time, you will receive either the new medicine, Rocatinlimab, or a dummy medicine (a placebo). You won't know which one you are getting, and neither will your study doctor. This is standard practice in medical research to ensure fair results. You will need to attend regular appointments at 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 may also be asked to keep a daily record of your itching. At these visits, assessments will be made to see how your eczema is improving and if you are experiencing any side effects. After the 24 weeks of treatment, there will likely be a follow-up period to see how you are doing.
Potential risks and benefits
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Common questions
What is Rocatinlimab?
It's a new medicine being tested to see if it can help adults with moderate to severe eczema.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know which treatment you are receiving until the study is over. This is called 'double-blind'.
How long will the study last?
The main treatment period for this study is 24 weeks.
What will treatment involve?
You will regularly receive either Rocatinlimab or a placebo, and your health and eczema symptoms will be checked during clinic visits.
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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