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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.

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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.

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Trial Information

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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.

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.