A clinical study is a medical research study involving people. It tests the use of a medical procedure, medical device, drug, or potential treatment, and is led by researchers and study doctors. Clinical studies provide valuable information and help us to improve healthcare. They can help us to understand a condition better and learn how best to treat it, and can lead to new treatments being made available.

It is important to involve children in clinical research studies because children have different treatment needs from adults–they need different doses of medication and types of therapies. Also, children sometimes have different medical conditions from adults. More relevant clinical research involving children is essential to increase our understanding of childhood conditions and improve pediatric healthcare.

Consent and assent both involve an agreement to take part in a clinical research study. Consent may only be given by people who have reached the legal age of consent in their location. This is usually 18 years of age. Assent is the agreement of someone who cannot give legal consent to participate in the study. Work with children requires the consent of the parent or legal guardian, and the assent of the study participant.

‘Informed consent’ means that the person giving consent understands what happens in the study and what the benefits and risks of taking part in the research study are. It also includes agreeing to participate in the study. Participation is voluntary and consent can be withdrawn at any time. The informed consent process involves the study team clearly communicating the nature of the research and everything that is involved and happens in the study, including risks and benefits. After this, and if the person agrees to participate, an informed consent form and/or assent form is signed and dated to document this conversation.

A placebo is a pill, injection, or other substance that looks similar to the drug under investigation, but it does not contain any active drug or medicine, i.e. it doesn’t contain any drug or medicine that is meant to affect a person’s health.

In the CIMcare study, the placebo is a saline solution, i.e. a solution containing a similar amount of salt as is already present in the human body. As the study drug will be given as an injection, the placebo will also be given as an injection.

Sometimes, people receiving placebos can experience improvements in their health or what appear to be side effects, even though the placebo contains no active medication.

This is called the ‘placebo effect’ and it can be caused by a number of psychological factors, including expectations. For example, just expecting the placebo to improve health has been known to make a person feel better.

If your child receives the placebo for the first 16 weeks, they will be receiving a substance that is not intended to treat their psoriasis or have any other effect on their health. However, they may experience a placebo effect.

After the first 16 weeks, your child will receive CZP for the rest of the study.

Your child’s participation in this study may last up to 169 weeks (just over 3 years), but you and your child are free to withdraw from the study at any time. If you wish to withdraw your child from the study, or if your child wishes to withdraw from the study, please contact the study site personnel.

All medications, both those that are approved and those undergoing clinical studies, may potentially cause side effects. Some of these are known, but there could be others that have not previously been seen. Study procedures may also involve risks. You will be informed by the study team about all of the known potential side effects of the study drug and study procedures. If any further risks are discovered while the study is ongoing, you and your child will be informed immediately.

Your child is free to leave the study and you are free to withdraw them from the study at any time and this will not affect their future care in any way.

If your child’s condition gets worse after they start the study, the study team will discuss additional or alternative treatment options with you and your child, if necessary. These options may include: continuing with the study drug, withdrawing from the study, switching to a different type of treatment, or taking medication to relieve the symptoms.

Your child’s health and well-being are of the utmost importance during the study, and any decisions regarding the study drug or alternative treatments will be made with that in mind.

Your child’s data will be collected, handled, and processed in compliance with applicable regulatory guidelines. It will not be shared with anyone other than in circumstances that will be explained in your informed consent form.

The study team will keep your child’s identity strictly confidential. At the start of the study, your child will be assigned a unique number. Any data sent to the study sponsor–that is, the company who are running the study–will be identified only by this number.