Study on Long-term Safety of Apremilast in Children Aged 6-17 with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called Apremilast (also known by its code name CC-10004) in children and teenagers aged 6 to 17 who have moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The medication being tested, Apremilast, is taken in the form of film-coated tablets.

The purpose of the study is to evaluate how safe Apremilast is for young patients over an extended period. Participants in the study will take the medication orally, and the study will monitor them for any side effects or changes in their health. The study will also keep track of their growth, including height and weight, and assess their development over time. Additionally, the study will use a questionnaire to monitor any changes in mood or behavior, such as depression or suicidal thoughts.

Throughout the study, participants will have regular check-ups to ensure their well-being and to gather information on how the medication affects them. The study aims to provide valuable insights into the long-term use of Apremilast in treating plaque psoriasis in young people, helping to determine its safety and effectiveness for this age group.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your height, weight, and body mass index (BMI) will be measured. These measurements help monitor your growth throughout the study.

You will also undergo an assessment of your sexual maturity, known as Tanner Staging. This assessment will be repeated every 52 weeks and at the end of the study if you leave early.

A questionnaire called the Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to monitor your mood and any thoughts of self-harm. This will be done throughout the study.

2 medication administration

You will be given a medication called Otezla, which comes in the form of film-coated tablets. The tablets are taken by mouth.

The dosage of Otezla will be 10 mg, 20 mg, or 30 mg, depending on your specific needs as determined by the study team.

You will take the medication as directed by the study team, and the duration of administration will be explained to you during the study.

3 regular follow-up visits

You will have regular follow-up visits where your height, weight, and BMI will be measured again to monitor your growth.

The Tanner Staging assessment will be repeated every 52 weeks to track any changes in your sexual maturity.

The C-SSRS questionnaire will continue to be used to monitor your mood and any thoughts of self-harm.

4 end of study

At the end of the study, or if you leave early, you will have a final visit. During this visit, your height, weight, and BMI will be measured one last time.

The Tanner Staging assessment will be conducted again to provide a final evaluation of your sexual maturity.

The C-SSRS questionnaire will be completed to ensure your mood and thoughts are stable.

Who Can Join the Study?

The participant must be a boy or girl aged between 6 and 17 years old.
The participant must weigh at least 20 kilograms (about 44 pounds).
The participant’s Body Mass Index (BMI), which is a measure of body fat based on height and weight, must be no lower than the 5th percentile according to the Centers for Disease Control (CDC) growth chart for children and adolescents.
The participant must have completed Week 52 of a previous study called Study CC-10004-PPSO-003.
The participant must be able to sign an assent form, which is a document showing they agree to participate, and have a legal guardian who understands and signs an informed consent form before any study-related activities are done.

Who Cannot Join the Study?

Patients who do not have moderate to severe plaque psoriasis cannot participate. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
Children younger than 6 years old and older than 17 years old cannot participate.
Patients who are not comfortable with the long-term use of the study medication cannot participate.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other health conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent infection or illness that could affect the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
CHU Saint Pierre	Brussels	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Synexus Czech s.r.o.	Prague	Czechia
&liztvwzketmhgi Sne Gjupljbj da Dyrn Cnfcgzy Dsnastaoqckutpnftayk	Cagliari	Italy
Cyfonztzt Uazfqlupoxfwav Shyfphadh	Woluwe-Saint-Lambert	Belgium
Hbwntfup Ucdontsrttwyr Mcigdda Dr Viksapezdw	Santander	Spain
Fqyddfzop Povy Ll Ioncjhsjzagqh Bfdgxgnib Dco Hmianvrv Uzqhfilxhdpjm Lb Pyw	Madrid	Spain
Hhijltgl Umqjufchkcnbl Hzujvhtv Tmofu y Pnwfma Iloemfmo Cmhocj dlutnmxenhodebwrc (pbrz	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	18.12.2019
Czechia	Not recruiting	18.12.2019
Italy	Not recruiting	18.12.2019
Spain	Not recruiting	18.12.2019

Trial locations

Apremilast is a medication used in this clinical trial to help manage moderate to severe plaque psoriasis in children and adolescents aged 6 to 17 years. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. Apremilast works by reducing inflammation in the body, which can help decrease the symptoms of psoriasis, such as redness and scaling. This study aims to evaluate the long-term safety of using Apremilast in young patients, ensuring that it is a safe option for managing their condition over an extended period.

Moderate to Severe Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches or plaques on the skin. These plaques often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The disease progresses through cycles, with periods of flare-ups followed by times of remission. During flare-ups, the plaques can become itchy, painful, and may crack or bleed. The severity of the condition can vary, with moderate to severe cases involving more extensive skin coverage and more significant impact on quality of life. The exact cause of plaque psoriasis is not fully understood, but it involves a combination of genetic, immune, and environmental factors.

Trial ID:

2023-503600-83-00

Protocol code:

CC-10004-PPSO-004

NCT ID:

NCT04175613

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety of Apremilast in Children Aged 6-17 with Moderate to Severe Plaque Psoriasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?