About Clinical Studies

What is a clinical study?

Clinical research studies (also called clinical trials) are critical for advancing the treatment of medical conditions and diseases. All drugs must be tested in clinical research studies before they can be approved and prescribed to patients.

During a clinical study, researchers may want to find out the following about an investigational drug:

If it has manageable side effects
If it works the way it is expected to
If it works less well, the same or better than other drugs
How it behaves in the human body (e.g. where is it transported, how quickly it leaves the body, etc.)

Types of clinical studies

There are 4 steps in the clinical research process, called “phases”. Each phase has a different purpose to help researchers answer different questions.

Early phase studies may look at whether a drug is safe or causes side effects. Later phase studies may compare the drug with other treatments already approved for the same purpose.

Phase 1

We test the investigational drug in a small group people, usually healthy volunteers. We’re looking at how safe it is, how the body handles it. This helps us find the right dose and learn more about side effects.

Phase 2

We give the investigational drug to people who have the condition we’re trying to treat. We check if it’s effective and continue to monitor its safety. This phase helps us understand how well it works and refine the dosage.

Phase 3

We test the investigational drug in a much larger group of patients. We compare it to existing treatments or a placebo (inactive treatment). This phase confirms if it’s well-tolerated and effective. If the investigational drug successfully finishes phase 3, it can be submitted to health authorities to get approval for more widespread use.

Phase 4

This happens after the investigational drug is approved and available to patients. We keep track of its long-term safety and effectiveness in real-world use. We might also study it for new uses or in different patient groups.

Sometimes a drug that has already been approved undergoes additional testing to collect information about how it affects people in specific circumstances. This is what is happening in the BE CARING Study.

The BE CARING Study is classified as a Phase 1b study.

Clinical research in pregnant or breastfeeding women

Clinical research in expecting and nursing mothers can be difficult because of the challenges in ensuring the safety for both the mother and the baby. Testing new drugs on pregnant or breastfeeding women can be risky, because while the medication may help the mother’s condition, there is a potential for harm to the developing baby or other negative effects on the mother's health. As a result, researchers often avoid including these groups in clinical trials, leading to a lack of information about the safety and effectiveness of many drugs for them.

Clinical research studies are essential for advancing the treatment of medical conditions and diseases. However, the concern associated with testing new drugs on pregnant or breastfeeding women means that there is less data available, making it difficult to draw conclusions about which medications can be recommended for these groups.

Who is involved in clinical studies?

Clinical studies take place in clinics, hospitals, or other healthcare facilities. For some studies, it is possible for the study assessments to be carried out at the patient’s home or another location, with a qualified nurse visiting to perform assessments and check on their well-being.

During a clinical study, you will be supported by a dedicated team of researchers, doctors, and nurses. Each member of the study team is committed to your health and well-being. At each phase of drug development, government agencies check the results to see whether the drug can continue to the next phase or whether the medication can also be used in other groups of patients or in other diseases.

By joining a clinical study like the BE CARING Study, you have the opportunity to possibly help other women in the future who are facing the difficult decision of whether to take bimekizumab while they are breastfeeding.

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