The purpose of this study is to help us understand how effective a drug called certolizumab pegol (CZP) is in the treatment of moderate to severe chronic plaque psoriasis, how safe it is to use CZP in participants aged 6 to 17 years old, and how it works on your child’s general health-related wellbeing.

It will also help us understand how CZP acts in your child’s body, how your child’s body reacts to CZP, and the concentration of CZP in the blood (amount of CZP in a given volume of blood) during study treatment.

CIMcare is exploring a potential treatment, known as certolizumab pegol (CZP), to see if it can reduce psoriasis symptoms in children and teenagers.

 A number of studies have already shown that CZP can reduce psoriasis symptoms in adults.

This study is not suitable for everyone. To be eligible to participate in this study, you must meet the following requirements. Some of those requirements are:

Moderate to severe plaque psoriasis diagnosed at least 6 months ago.

Your child is between the ages of 6 and 17 years and weigh more than 20 kg at study start.

Your child’s study doctor agrees that your child is able to participate.

Your child’s study doctor would consider using a treatment that will be injected.

You and your child agree to attend the scheduled appointments, follow the instructions given to you and your child and take the study medication according to the directions given.

Your child is not pregnant, breastfeeding, or planning a pregnancy.

Your child must meet other requirements as well. The study doctor can give you further details.

Certolizumab pegol (CZP) may or may not be beneficial in treating your child’s illness and improve your child’s symptoms. However, if you decide to allow your child to participate, your child will have the following benefits:

• Regular appointments with the study doctor including regular health and psoriasis status checks, in addition to the medical care your child is already receiving.
• Receiving the study drug free of charge.
• Contributing to the advancement of knowledge, which might serve other people suffering from moderate to severe chronic plaque psoriasis.

Taking part in a clinical study can also have risks. Your child’s study doctor can inform you about potential side effects of the study drug.

CZP belongs to a group of medicines called Tumor Necrosis Factor (TNF) blocker. The following side effects have been seen in people taking TNF blocker medicines like CZP.  

• Serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have caused hospitalization and death.
• Cases of cancer (certain types of blood cancer and skin cancer) have been reported in patients treated with CZP, but it is not known if these were caused by taking CZP.
• Your child may also develop other side effects like rash, damage to liver, production of fewer and abnormal red blood cells, and damage to the nerves.

There may be changes to your child’s treatment during the study, which may affect your child’s disease.

• Your child’s general health will therefore be closely monitored by the study doctor and study team.
• Your child’s other medications will be documented and carefully monitored during this study.
• There are several types of medicines and vaccines that must not be used during the study. The study doctor will check that your child is not taking these before entering the study. Thus, it is important you tell the study doctor before you change any of your child’s medication.

The study lasts approximately 169 weeks (3.25 years)

During that time, your child will be asked to attend at least 26 appointments with the study doctor, with the option to have some of these visits performed at your home.

Your child will be receiving CZP injection under the skin.

You/your child will be asked to complete questionnaires about his/her disease activity and quality of life and give blood and urine samples. 

If your child has mixed guttate/plaque psoriasis and if you agree and sign a consent, photographs of your child’s skin and nails will be taken.

Your child’s travel costs may be reimbursed.

A study like this requires you/your child’s cooperation. Therefore, it is important that you/your child follow all of the instructions given by the study doctor and site study team.

Many people want to participate in scientific discovery and contribute to the health of others. By participating in the CIMcare study, your child is lending his/her support to an important health research.

This type of research is the only way to test and further develop new treatment options and to improve the lives of people with conditions such as moderate to severe chronic plaque psoriasis.

We would be delighted if you considered participating in the study!

Contact person: Priscila Valdiviezo

Email: pvaldiviezo@lakesresearch.com

Phone contact: 7863625763 ext. 122