How do Clinical Trials Work?
A clinical trial studies a potential medicine to answer these key questions: 1) How safe is it? 2) Does it work? 3) Does it cause any side effects? If the new medicine is approved by regulators, a doctor can then prescribe it to treat a disease or condition.
Preclinical
Answers basic questions about an investigational medicine's safety. Lab and animal testing happen before starting clinical trials with people.
Phase 1
Studies the overall safety and treatment dose. Researchers study how the potential new medicine works in the body. People in this phase are often healthy volunteers, with no known major health concerns.
Phase 2
Continues to study the safety of the potential medicine and the best dose. Researchers also study how it works and possible side effects.
Phase 3
Studies the safety and effects of the potential medicine in a large group of people. It is often compared to a placebo, which has no active ingredients. It may also be compared to a "standard of care," which is the currently available treatment people typically receive. Or it may be compared to other treatments for the specific disease.
Phase 4
Studies the long-term risks and benefits of the new treatment. Phase 4 trials happen after the potential medicine is approved for use.
Trial Information
Asthma is one of the top reasons people end up in the emergency room (ER) or hospital around the world. In the U.S. alone, almost 1 million people went to the ER because of asthma, and most of them were adults. Even after getting emergency treatment, many people still struggle with asthma symptoms. About half need more medicine in the first month, and around 1 in 5 may need to go back to the ER or urgent care. That’s why it’s important to find better treatments to help people recover after a serious asthma attack.
The Seabreeze STAT Asthma study (NCT0694014) is testing a potentially new medicine called rademikibart to see if it can help prevent asthma symptoms from getting worse again right after a flare-up. Everyone in the study will keep taking their usual asthma medications, and on top of that, they’ll get either rademikibart or a placebo (a shot with no active medicine). The medicine or placebo will be given as a single shot under the skin during your urgent care visit. The study is for people who have high levels of a certain white blood cell (called eosinophils) and are having an asthma attack. There’s a 50/50 chance of getting the real medicine or the placebo. Either way, you’ll continue receiving all the standard treatments for your asthma, and the research team will check in with you over the next few months to see how you're doing.
For an overview of the Seabreeze STAT Asthma study, visit clincaltrial.gov.
Criteria
Below are select criteria for the clinical trial, your doctor has a complete list of entry criteria that will be reviewed prior to study entry. For further information on eligibility criteria, please visit clinicaltrials.gov.
Select Inclusion Criteria
Select Exclusion Criteria
Adults and adolescents ≥12 to ≤75 years at the time of signing the informed consent/assent
Body weight of ≥40 kg at Screening
Physician-diagnosed COPD with duration of ≥12 months
Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening
Previously received rademikibart; or a known history of systemic hypersensitivity or anaphylaxis to any biologic therapy, including any excipients
Scheduled elective surgery or other procedures requiring general anesthesia during the trial
Previous intubation for a severe asthma exacerbation
Unstable ischemic heart disease, cardiomyopathy, heart failure, or uncontrolled hypertension
Current or former smoker with the following criteria:
a. If <30 years old: Smoked for ≥5 pack-years
b. If ≥30 years old: Smoked for ≥10 pack-years
Transient ischemic attack or stroke in the last 6 months or hospitalization for any cardiovascular or cerebrovascular event in the last 6 months
FAQs
For additional information, please contact the Connect Biopharma Clinical Study Team:
Rademikibart is an investigational agent that has not been approved for marketing by the U.S. Food and Drug Administration, the European Medicines Agency, or by any other regulatory agency. Images do not depict actual trial participants.
