
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 is given as a one-time injection 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
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What is a Clinical Research Study?Clinical research studies, also called clinical trials, are used to find out if a new medication works and if it's safe. These studies are run by qualified doctors, who take care of the people who choose to take part. Clinical research is a required step before any new drug can be approved by regulatory agencies, like FDA or EMA, and made available to the public. There are also independent groups — called Institutional Review Boards (IRBs) or Ethics Committees — that include both medical experts and non-medical people. Their job is to make sure participants are fully informed and protected throughout the study.
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What is Informed Consent?Informed consent is an important too to help you understand how your rights, safety, and well-being will be addressed throughout the clinical trial. During informed consent, you will be given all details about the study you are considering. This will include potential benefits and risks of the study. This information will help you decide whether you would like to participate. A member of the study team will walk you through the informed consent document and answer any questions you may have before you agree to participate and sign in. You can take as much times as you need to review it. While you are participating, the study team will tell you in a timely manner if new information is learned that could change your mind about continuing in the study. You can stop participating in the study at any time. Your decision will not affect your regular medical care or any benefits to which you are entitled.
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What are my rights as a participant?As a participant in a clinical trial, you have many rights. Among them are the rights to: Leave the study at any time Ask questions about any aspect of the study Understand the goal of the study and what you will be asked to do Understand who will have access to information about you Understand all of the risks and possible benefits of participating Have your identify remain confidential Understand how your identify is being protected
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How long is the Seabreeze STAT COPD study?The study is eight weeks in duration, which includes four weeks of assessment and four weeks of safety follow-up.
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What is an Institutional Review Board (IRB)?An IRB, also known as an Independent Ethics Committee (IEC), is an independent group that includes scientists, doctors, and lay people. This group reviews a clinical trial's design and any updates to it, as well as any information provided to participants, to ensure that participant's rights, safety, and well-being are protected. IRBs and IECs have the authority to approved, ask for changes, or disapprove clinical research.
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What is a Data and Safety Monitoring Board (DSMB)?A DSMB is typically made up of a group of external, independent experts who monitor any potential safety concerns that may develop during a clinical trial.
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.
