
How do Clinical Trials Work?
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
People with COPD sometimes have sudden flare-ups that require immediate care in an emergency room, hospital, or urgent care facility. For some, these flare-ups are more frequent due to a type of inflammation linked to high levels of eosinophils (a type of white blood cell). Even after treatment, many people experience another flare-up within a month.
The Seabreeze STAT COPD study (NCT06940154) is testing whether a potentially new medication called rademikibart, when added to standard COPD treatment during a flare-up, can help reduce the risk of symptoms returning or getting worse in the 28 days after urgent care. If you qualify, you’ll receive either rademikibart or a placebo (a harmless, inactive substance), along with all usual COPD medications. The study drug or placebo will be given as four injections under the skin during your urgent care visit. Afterward, the research team will follow up with you over the next few months to monitor your health. You have a 1 in 2 (50%) chance of receiving placebo, but you will continue to receive standard care medications to manage your COPD regardless of which group you're in.
For an overview of the Seabreeze STAT COPD study, visit clinicaltrials.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 (40 to 80 years, inclusive) at the time of signing the informed consent

Body weight of ≥45 kg and body mass index within the range 16 to 35 kg/m2 (inclusive) at Screening

Physician-diagnosed COPD with duration of ≥12 months

Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening

Current or former smoker with a history of smoking of ≥10 pack-years

Previously received rademikibart; or a known systemic hypersensitivity or anaphylaxis to any biologic therapy, including any excipients

Regular use of immunosuppressive medication (including but not limited to maintenance daily prednisolone, hydrocortisone, azathioprine, or weekly methotrexate) 12 weeks or 5 half-lives prior to randomization, whichever is longer

Current diagnosis or a history of asthma, or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome

Other respiratory disorders: A diagnosis of alpha-1 antitrypsin deficiency as the underlying cause of COPD, lung cancer, clinically overt bronchiectasis, primary pulmonary hypertension, or interstitial lung diseases

Unstable ischemic heart disease, cardiomyopathy, heart failure, or uncontrolled hypertension

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.
