RecruitingPHASE2INTERVENTIONAL

Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)

This research study, called Seabreeze STAT Asthma, is investigating a new medication, rademikibart, for people experiencing a sudden and severe asthma attack. These are often called 'acute asthma exacerbations'. The study is in its second phase and involves adults and teenagers whose asthma attacks are linked to a specific type of inflammation called 'type 2 inflammation'. Participants will randomly receive either rademikibart plus their usual asthma treatment, or a placebo (inactive substance) plus their usual asthma treatment. The aim is to see if rademikibart helps people recover from their severe asthma attacks more effectively when added to their standard care, particularly when they need urgent medical attention.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Connect Biopharm LLC

Enrolment target

160

Start

08 Aug 2025

Estimated completion

01 Jul 2026

Asthma Acute

What is this study about?

This study, named Seabreeze STAT Asthma, is exploring a new treatment called rademikibart for sudden, severe asthma attacks, often referred to as acute asthma exacerbations. Asthma can sometimes flare up unexpectedly, leading to breathlessness, coughing, and wheezing that requires urgent medical attention. This study focuses on people whose asthma attacks are thought to be driven by a specific type of inflammation in the body, known as 'type 2 inflammation'.

The main goal is to find out if adding rademikibart to the standard care someone receives during an acute asthma attack can help them get better. Standard care usually involves medications like steroids to reduce inflammation quickly. Researchers want to compare what happens when people get rademikibart on top of their usual treatment, versus those who get a 'matching placebo' (an inactive substance that looks just like the real drug) plus their usual treatment. This helps them understand the true effect of rademikibart.

This is a 'Phase 2' study, which means it's still relatively early in the research process. It's designed to give a clearer idea of how well rademikibart works and to continue checking its safety in a larger group of people. The study is 'randomised', meaning participants are put into groups by chance, and 'double-blind', meaning neither the participants nor their doctors will know who is receiving rademikibart and who is receiving the placebo. This helps ensure the results are as fair and unbiased as possible.

Key takeaways

This study is testing a new drug, rademikibart, for sudden, severe asthma attacks.
It aims to see if adding rademikibart to usual care helps people recover better.
The study includes adults and teenagers with 'type 2 inflammation' related asthma.
Participants will randomly receive either rademikibart or a placebo alongside their standard treatment.
It's a 'Phase 2' study, focusing on effectiveness and safety.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you would need to be an adult or teenager (between 12 and 75 years old) who has been diagnosed with asthma for at least a year. You should currently be using asthma inhalers with steroids (at low, medium, or high doses) along with at least one other asthma controller medication. You must also have had at least one asthma attack in the past that required steroid tablets or injections.

Crucially, you would need to be experiencing a sudden, severe asthma attack right now that requires urgent medical care. Your blood test results taken at this time should show a certain level of a type of white blood cell called 'eosinophils', which indicates 'type 2 inflammation'. Your lung function, measured by a breathing test (FEV1), should also be at a certain level, and you must need steroid tablets or injections as part of your usual care for this current attack.

There are also some reasons why you wouldn't be able to join. These include taking regular medications that suppress your immune system, having certain heart conditions, a history of significant smoking, other serious lung diseases like COPD, or a history of certain cancers or immune system problems. Pregnant or breastfeeding women also cannot participate, nor can those who have recently used other similar biologic medications or had certain vaccinations.

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 12 and 75 years old?
Do you have asthma diagnosed for at least a year and are currently using steroid-based inhalers plus another controller?
Have you had an asthma attack in the past that needed steroid tablets or injections?
Are you currently having a severe asthma attack requiring urgent medical attention?
Are your blood tests showing signs of 'type 2 inflammation' (e.g., higher eosinophil count)?
Do you NOT have serious heart conditions, significant smoking history, or certain other lung diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new study medication, rademikibart, or a placebo (an inactive substance). Both rademikibart and the placebo are given as an injection in a pre-filled syringe. You would receive this in addition to the standard treatments your healthcare team decides are best for your acute asthma attack.

The study would involve several visits to the clinic or hospital for assessments. These would include blood tests to check your eosinophil levels, breathing tests (like FEV1), and discussions about your symptoms and how you are feeling. The exact number and timing of visits, as well as the total duration of your participation, would be explained in detail by the study team. They will monitor your health closely throughout the process, and there will be follow-up appointments to track your recovery and any effects of the study medication.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of joining this study is that rademikibart might help you recover from your acute asthma attack more quickly or effectively than standard care alone. However, it's also possible that you could receive the placebo and not experience any additional benefit from the study medication. Potential risks include side effects from rademikibart, although these will be closely monitored. The study team will provide comprehensive information about all known and potential risks before you decide to participate. Remember, your participation 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 (52)

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

Leland Stanford Junior University, Stanford Hospital
Verified postcode
Palo Alto, United States· Recruiting
Amicis Research Center
Verified postcode
Valencia, United States· Recruiting
Synergy Healthcare
Verified postcode
Bradenton, United States· Withdrawn
Pharmax Research of South Florida, Inc.
Verified postcode
Miami, United States· Recruiting
Columbus Clinical Services, LLC
Verified postcode
Miami, United States· Recruiting
Health Synergy Clinical Research, LLC
Verified postcode
West Palm Beach, United States· Recruiting
Primeway Clinical Research Group
Verified postcode
Fayetteville, United States· Recruiting
Pivotal Research Solutions
Verified postcode
Stonecrest, United States· Recruiting
University of Iowa
Verified postcode
Iowa City, United States· Recruiting
University of Kansas Medical Center
Verified postcode
Kansas City, United States· Recruiting
Allergy & Asthma Specialists, P.S.C.
Verified postcode
Owensboro, United States· Recruiting
Chesapeake Clinical Research, Inc.
Verified postcode
White Marsh, United States· Recruiting

Common questions

What is 'type 2 inflammation'?

Type 2 inflammation is a specific kind of immune response in the body often linked to allergic conditions like asthma, eczema, and hay fever. Doctors can sometimes identify it through blood tests (like eosinophil count) or breathing tests (like FeNO).

What is a 'placebo'?

A placebo is an inactive substance that looks exactly like the actual study medication. It's used to compare against the real drug to see if the new treatment has a genuine effect, beyond what might happen naturally or from other treatments.

What does 'randomised' and 'double-blind' mean?

Randomised means you are assigned to a treatment group by chance, like flipping a coin. Double-blind means neither you nor your study doctors will know whether you are receiving the active drug or the placebo. This helps make the study fair and unbiased.

Will I still get my usual asthma treatment?

Yes, if you participate, you will still receive the standard treatments that your doctors recommend for your acute asthma attack. The study treatment (rademikibart or placebo) would be given in addition to your usual care.

Can I leave the study if I change my mind?

Absolutely. Your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Radha Adivikolanu

clinical206@connectpharm.com 213-522-7990 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.