A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma
This clinical trial is looking at a potential new treatment called rocatinlimab for adults living with moderate-to-severe asthma. Even with regular daily inhalers, many people still experience sudden chest tightness, wheezing, and severe flare-ups that require urgent medical attention. In this study, researchers are comparing different doses of rocatinlimab against a placebo, which is a dummy treatment containing no active medicine. The main goal is to find out if rocatinlimab can safely reduce the number of severe asthma attacks—specifically those that lead to emergency hospital visits or require a course of steroid tablets for three days or more. Participants will also complete daily symptom diaries so doctors can see if the treatment improves everyday breathing and quality of life. The findings will help determine if rocatinlimab could become a helpful new option for people whose asthma remains difficult to manage.
At a glance
What is this study about?
Asthma is a long-term condition that causes the airways to become swollen, narrow, and sensitive. While many people manage their symptoms well with everyday preventer and reliever inhalers, others have moderate-to-severe asthma. For these individuals, breathing difficulties and sudden chest attacks can continue to disrupt daily life, often leading to courses of steroid tablets, visits to A&E, or hospital stays.
This clinical trial is evaluating an experimental medicine known as rocatinlimab (also called AMG 451). Rocatinlimab works by targeting specific parts of the immune system that cause inflammation in the lungs. By calming this inflammation, scientists hope the medicine will stop airways from swelling up and prevent serious attacks before they start.
The trial is 'double-blind' and 'placebo-controlled'. This means participants are placed into groups by chance to receive either different doses of rocatinlimab or a placebo (a lookalike treatment with no active drug). Neither the participants nor the study doctors will know who receives which treatment until the trial is complete. This standard setup helps ensure the results are fair and reliable.
By comparing rocatinlimab with a placebo, doctors hope to learn whether the medicine is safe, what the most effective dose is, and whether it can genuinely improve daily life for people with severe asthma. Research like this is vital for discovering new, targeted therapies for those who need more support than standard inhalers can offer.
Key takeaways
- Testing a new medicine called rocatinlimab for adults with moderate-to-severe asthma.
- Aims to reduce severe asthma attacks that lead to steroid tablets or hospital visits.
- Compares different doses of the medicine against a dummy treatment (placebo).
- Open to adults aged 18 and older with asthma that is difficult to manage.
- Involves regular health visits, breathing tests, and keeping a daily symptom diary.
- Participation is voluntary and will not impact your normal NHS medical care.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with moderate-to-severe asthma. It is aimed at people whose asthma symptoms are not fully settled and who may still experience frequent or difficult flare-ups.
Both men and women can take part. To qualify, you must have medical records confirming your asthma diagnosis, and your breathing needs to be measured during the trial's initial screening process.
You might not be able to join if you have other serious lung conditions, certain ongoing medical issues, or if you are taking specific medications that could clash with the study drug. The clinical research team will review your full medical background with you to make sure it is completely safe for you to take part.
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.
- I am aged 18 or older.
- I have a confirmed medical diagnosis of moderate or severe asthma.
- I still experience asthma symptoms or attacks despite using my regular inhalers.
- I am willing to attend regular hospital or clinic appointments for monitoring.
- I can complete a daily diary to record my asthma symptoms.
What does participation involve?
Taking part involves regular visits to a hospital clinic or clinical trial centre over several months. During these visits, doctors and nurses will check your general health, measure your lung function using breathing tests, and take routine blood samples to monitor your safety and check drug levels. You will receive either rocatinlimab or a placebo, given as an injection or dose according to the trial schedule. You will also be asked to keep a daily asthma diary to record your symptoms and inhaler use. Throughout the study, the research team will track any asthma attacks you experience and follow up on your progress carefully.
Potential risks and benefits
Locations (5)
- —UnverifiedRomania
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedBulgaria
Common questions
What is rocatinlimab?
Rocatinlimab is an experimental medicine designed to reduce lung inflammation by calming specific signals in your immune system that trigger asthma attacks.
What is a placebo and why is it used?
A placebo looks just like the trial medicine but contains no active ingredients. It helps researchers prove whether improvements are truly caused by rocatinlimab rather than other factors.
Will I have to stop taking my regular asthma inhalers?
No, you will usually continue using your prescribed background asthma medicines. The study team will explain exactly how to manage your daily treatments safely.
How often will I need to visit the clinic?
Visits are typically scheduled every few weeks for health checks, breathing tests, and treatments. The trial staff will provide a detailed calendar before you agree to join.
Can I leave the study if I change my mind?
Yes, taking part is entirely your choice. You can withdraw at any time, for any reason, and your regular doctor will continue your normal asthma treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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