Is living with psoriasis impacting your child’s life?

An ongoing clinical research study may be an option for your child.

GET STARTED – CHECK IF YOUR CHILD PRE-QUALIFIES

Short Study Summary

Medical condition:

Pediatric Psoriasis

Participation duration:

Screening: up to 5 weeks
Initial Treatment Period: 16 weeks ~ 4 months
Maintenance Period: 32 weeks ~ 8 months
Open Label Extension: Approximately 2 years
Safety Follow Up Period: ~ 4 months
Total duration of study: A little more than 3 years

Phase: 3

Phase 3 is where the investigational drug is evaluated for efficacy and safety in a larger group of people.

GET STARTED – CHECK IF YOUR CHILD PRE-QUALIFIES

What is Psoriasis

Psoriasis is a common, chronic inflammatory disease characterized by inflammation of the skin. Plaque psoriasis is the most common form of the disease, and usually results in areas of red, inflamed skin, often covered with silver-colored scales on areas of the skin. The plaques can be painful as the skin cracks and bleeds. In severe cases, plaques grow and merge into one another, covering large areas. Psoriasis can affect people of any age and is essentially similar in adults and children.

What is the BE TOGETHER study?

The aim of the BE TOGETHER study is to learn more about the investigational drug and evaluate the effectiveness and safety when taken by children and adolescents living with psoriasis. Investigational means that the drug is not currently approved by Health Canada for this patient population except for in research studies like the BE TOGETHER study.

The study is a randomized study, meaning that participants are randomly assigned to one of two groups:

Investigational drug
Comparator drug

Your child has a 2 out of 3 chance of being assigned the investigational drug. The study is double-blind, meaning neither you, your child nor the study doctors will know which group your child is assigned to. Your child will be closely monitored by the study doctor and study staff at the site independent of which group your child is in.

You will not have to pay for your child’s participation in the study or for the investigational or comparator drug.

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Who can participate in the BE TOGETHER study?

Your child may be eligible to participate in the BE TOGETHER study if they:

Are 6 – 17 years of age

Have had a medical diagnosis of psoriasis for at least 3 months

Have at least 10% of their body affected by psoriasis

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What happens if my child participates?

Before you decide if your child would be interested in taking part in this research study, the study doctor will provide you with information about the study and what it means to participate. Part of the study information provided by the study doctor, is an informed consent document and an assent form for your child. Please take your time and read this information carefully. It is important that you and your child ask your study doctor if something is unclear or if you have any questions about the study before you both sign the informed consent and assent forms. Whether or not you and your child decide to join the BE TOGETHER study is completely you and your child’s decision. You and your child can withdraw at any time and for any reason.

If you and your child choose to participate, there are a few different periods of the study:

Screening Period

(up to 5 weeks)

This is the time when the study doctor and staff determine if your child is eligible for the study, and you and your child decide if your child wants to participate. During this period, your child will need to undergo some tests and assessments. This will include a medication review for current psoriasis treatments, blood and urine tests and assessment of their psoriasis.

Initial Treatment Period

(16 weeks ~ 4 months)

During this period, you and your child will visit the study site every month (a total of 5 visits). During their visits, they will receive the investigational or comparator drug and have some tests performed, such as blood and urine tests and assessment of their psoriasis. Throughout this time your child’s health will be continuously monitored.

Maintenance Period

(32 weeks ~ 8 months)

During this period, you and your child will visit the study site 6 times. During their visits, they will receive the investigational or comparator drug and have some tests performed, such as blood and urine tests and assessment of their psoriasis. Throughout this time your child’s health will be continuously monitored.

Open Label Extension Period

(Approximately 2 years)

After completion of the maintenance period, your child may be offered the opportunity to continue in a 2-year open label period and receive the investigational drug. During this period, your child will visit the study site every 8 weeks for 13 visits. The study team will continue to monitor your child’s health closely and perform other tests such as blood and urine tests and assessment of their psoriasis.

Safety Follow Up Period

(20 weeks)

There will be a follow-up period of 20 weeks after the last dose of the investigational drug or comparator drug. During the follow-up period, your child will have some tests like blood and urine tests, vital sign checks and assessment of their psoriasis.  

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How does my child participate?

Complete the online questions to see if your child pre-qualifies

Submit your contact information

Answer our call to respond to questions and learn more about the study

Confirm you and your child’s interest

Speak with the study site about the next steps for your child to participate

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Frequently Asked Questions

Where can I find more information about this study?

You can learn more about this study by visiting https://www.clinicaltrials.gov/study/NCT06425549.

What is a clinical research study?

Clinical research studies are scientific studies in which investigational drugs are tested to find out if they are well tolerated and effective for people to take and use. They are one of the most important steps in bringing potential medications or devices to patients.

Why is clinical research important?

Clinical research adds to medical knowledge and helps bring potential medications to people living with medical conditions. To bring medications to the public, they need to be assessed in clinical studies, to determine if they work and are well tolerated.

Clinical studies rely on the participation of volunteers. It can take several years for a potential medication to reach the public. Often, this timeline is due to how long it takes to complete the clinical study.

All approved prescription drugs have gone through clinical studies to make sure that they are effective and to understand what side effects may be involved.

Who runs clinical research studies?

Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centers, voluntary groups, or health care providers. The BE TOGETHER study is funded by a pharmaceutical company called UCB.

Every clinical study site is led by a principal investigator, who is a medical doctor. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals.

What are the phases of clinical research studies?

Clinical studies are conducted in different phases.

Phase 1: Researchers test an investigational drug or medicine in a small group of people for the first time to assess its safety.

Phase 2: The study investigational drug is given to a larger group e.g., 50-200 of people (compared to Phase 1) to see if it is effective and to further evaluate its safety.

Phase 3: The study investigational drug is given to large groups e.g., 100s-1000s of people to confirm its efficacy, monitor side effects, compare it to commonly used medications or placebo (an inactive substance), and collect information that will allow the study investigational drug to be used safely.