Active not recruitingPHASE2INTERVENTIONAL

A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

This research study is investigating a new medication called rocatinlimab for adults aged 18 to 75 who have moderate to severe asthma. The main goal is to find out how well rocatinlimab reduces the number of asthma attacks people experience. During the study, some participants will receive the new medicine, while others will receive a placebo, which looks like the medicine but contains no active drug. This helps researchers understand the true effect of rocatinlimab. The study will also look at different doses of the medicine. It's hoped that this research will help doctors find better ways to manage asthma and improve the lives of those affected by it.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Amgen

Enrolment target

317

Start

24 May 2024

Estimated completion

11 Dec 2026

Asthma

What is this study about?

This study is looking into a new medicine called rocatinlimab for people who have asthma that's moderate to severe. You might be wondering what 'moderate to severe' means. It generally refers to asthma that needs strong daily treatments to keep it under control, and even then, people can still have flare-ups or asthma attacks. The main aim of this study is to see if rocatinlimab can help reduce how often these asthma attacks happen. If it works, it could mean a big step forward in managing asthma and helping people live more comfortably.

Researchers also want to find out the best amount, or 'dose,' of rocatinlimab to give. Finding the right dose is important because it ensures the medicine is as effective as possible while keeping side effects to a minimum. To do this, some people in the study will receive different doses of rocatinlimab, while others will receive a 'placebo.' A placebo looks exactly like the real medicine but doesn't contain any active drug. This is a common and important part of medical research, as it helps doctors accurately judge if the new medicine is actually making a difference compared to no treatment.

By taking part in studies like this, volunteers help doctors and scientists learn more about new treatments. This knowledge is crucial for developing better ways to treat diseases like asthma in the future. The information gathered from this study could potentially help many people with asthma to breathe easier and have fewer disruptive asthma attacks.

Key takeaways

Tests a new medicine (rocatinlimab) for moderate to severe asthma.
Aims to reduce asthma attacks.
Involves adults aged 18-75 with an existing asthma diagnosis.
Will compare rocatinlimab to a placebo (dummy medicine).
Participation includes regular clinic visits and health checks.
Your safety and wellbeing are a priority throughout the study.

Who may be eligible?

This study is looking for adults aged between 18 and 75 who have had asthma for at least a year. You should be taking medium to high doses of an inhaled steroid (like fluticasone) every day, along with at least one other regular asthma medication. It's also important that despite these treatments, you've had at least one asthma attack in the past year, especially while on your current medication.

There are also some things that might mean you can't join. For example, if you've had a very recent severe asthma attack that needed emergency care or strong steroids, or if you have other serious lung conditions besides asthma. If you've smoked or vaped (including marijuana) in the last six months, or have a significant history of smoking, you also won't be able to take part.

Other reasons you might not be suitable include having had COVID-19 recently, especially if it was severe, or if you have an active infection that needs antibiotics. The study also needs to make sure your breathing test results (FEV1) fall within a certain range, and your asthma control score (ACQ-6) is at a certain level.

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 between 18 and 75 years old?
Have you been diagnosed with asthma for at least a year?
Are you currently taking daily inhaled steroids and another asthma medicine?
Have you had at least one asthma attack in the past year?
Have you avoided smoking or vaping for the last 6 months?
Have you recovered well if you've had COVID-19 recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have several visits to the clinic over a period of time. These visits will involve various checks, such as breathing tests, physical exams, and blood samples, to see how you're doing and how the medicine is affecting you. You will receive either the study medicine, rocatinlimab, or a placebo, which looks identical but has no active drug. Neither you nor your study doctor will know which one you are taking until the end of the study.

You'll be asked to take your study medication regularly as instructed. There will be regular check-ups to monitor your asthma and your general health. The length of the study isn't specified here, but it would involve consistent participation for a defined period, followed by potential follow-up checks. All procedures and details about the number of visits and exact duration would be fully explained to you before you decide to take part.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of trying a new medicine that could improve your asthma control and reduce asthma attacks. However, as with any new medicine, there might be unknown side effects or it might not work for you. You could also experience side effects from the study medication. You will be closely monitored by medical staff throughout the study. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (154)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Kern Research Inc
Verified postcode
Bakersfield, United States
Orso Health Inc
Verified postcode
La Jolla, United States
Imax Clinical Trials
Verified postcode
La Palma, United States
Antelope Valley Clinical Trials
Verified postcode
Lancaster, United States
Downtown Los Angeles Research Center, Inc
Verified postcode
Los Angeles, United States
NewportNativeMD, Inc
Verified postcode
Newport Beach, United States
University of California Irvine
Verified postcode
Orange, United States
Apex Clinical Research
Verified postcode
San Diego, United States
Allergy and Asthma Clinical Research
Verified postcode
Walnut Creek, United States
Allianz Research Institute Westminster
Verified postcode
Westminster, United States
St Francis Medical Institute
Verified postcode
Clearwater, United States
BioMed Research Institute
Verified postcode
Miami, United States

Common questions

What is rocatinlimab?

Rocatinlimab is a new medicine being tested to see if it can help people with moderate to severe asthma by reducing asthma attacks.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but has no active drug. It helps researchers compare the effects of the new medicine.

Will I know if I'm getting the real medicine or the placebo?

Neither you nor your study doctor will know whether you are receiving rocatinlimab or the placebo until the end of the study. This helps ensure fair results.

How long will the study last?

The full duration of the study isn't detailed here, but it will involve multiple visits and consistent medication use over a specific period, followed by potential check-ups.

What if my asthma gets worse during the study?

You will be carefully monitored by medical staff throughout the study, and your safety is the top priority. You can also withdraw from the study at any time if you wish.