Pediatric Plaque Psoriasis Ages 6-17

A phase 3 study for pediatric Patients 6 to 17 years of age with Moderate to severe plaque psoriasis

A short parent guide to this research study 

Patients that meet the following criteria may be eligible for the study.

1.Males and females 6 to 17 years of age at the time the informed consent form is signed by legal guardian.

2.Must weight ≥ 44 lbs or 20 kg.   

3.Able to swallow the study medication Tablet.

4.Has a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening. 

5.Has moderate to severe plaque psoriasis defined by:

PASI score ≥ 12, Body Surface Area (BSA) ≥ 10%, and sPGA ≥ 3 (moderate to severe). 

6.Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.

7.Candidate for systemic therapy or phototherapy.

What will happen during the study?

If you or your child decide to join the study, the study doctor will perform tests to determine if your child can take the study drug. 

If you join the study, you will see the study doctor about 1 time every month for a little more than 1 year.

During the study visits, the doctor may….

· Ask you about other medication you are taking 

· Talk to you about how you are feeling

· Measure your height and weight 

· Check your blood pressure, temperature, and heart rate 

· Look at your skin to see how the new medication is working 

· Take a small amount of blood for testing 

Your child may be able to take part in an observational research study for children with Atopic Dermatitis (AD), a skin condition also known as eczema. 

Who can take part?

Your child may be able to take part if he/she:

• is 11 years of age or younger

• is being treated for atopic dermatitis with pills, injections, or light therapy, OR

• is being treated with only lotions and creams (topical treatments), but still gets itchy skin when using these.

What will happen during the study? 

If the AD. Study is right for your child and you both choose to take part, your child will be in

the study for about 5 years. 

Your child will attend his/her usual doctor appointments and continue to take his/her regular medication.

The AD Study aims to learn more about atopic dermatitis (AD) in children. Atopic dermatitis (also known as Eczema) often causes skin to become dry, scaly, and very itchy. AD can look quite different from one child to another. 

AD is very uncomfortable for children and may have a significant impact on their self-esteem and social life.

We want to better understand AD in children whose skin condition cannot be well treated with topical therapies (creams or lotions) alone and may need to consider other treatments (such

as pills, injections, or light therapy). 

Subject must meet the following criteria to be eligible for study participation: 

1. Be an adult between 18 and 75 years of age at the screening visit (Screening) with atopic dermatitis (AD). 

2. Present for at least 1 year prior to the baseline visit (Baseline) with an inadequate response, in the judgement of the Investigator, to AD treatment with a topical regimen of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors.

What will happen during the study?

 If you or your child decide to join the study, the study doctor will perform tests to determine if your child can take the study drug. 

If you join the study, you will see the study doctor about 1 time every month for a little more than 1 year.

During the study visits, the doctor may...

· Ask you about other medication you are taking 

· Talk to you about how you are feeling

· Measure your height and weight 

· Check your blood pressure, temperature, and heart rate 

· Look at your skin to see how the new medication is working 

· Take a small amount of blood for testing