Study on Deucravacitinib for Children with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The study is testing a treatment called deucravacitinib, which is taken orally in the form of film-coated tablets or granules in a sachet. The treatment is being evaluated for its effectiveness and safety in children and teenagers aged 4 to 18 years who have this condition.

The purpose of the study is to understand how deucravacitinib works in the body, its effectiveness in improving the skin condition, and its safety for long-term use. Participants will be randomly assigned to receive either the medication or a placebo. The study will be conducted over a period of up to 52 weeks, during which participants will have regular check-ups to monitor their progress and any side effects.

Throughout the study, researchers will collect information on how well the treatment works in reducing the severity of the skin patches and improving the overall skin appearance. The study will also monitor the growth and development of the participants to ensure the treatment is safe for use in children and teenagers. This research aims to provide valuable insights into the treatment of moderate to severe plaque psoriasis in younger patients.

1 joining the study

Upon joining the study, you will be assigned to one of two groups based on your age. Cohort 1 includes individuals aged 12 to less than 18 years, and Cohort 2 includes individuals aged 4 to less than 12 years.

You will be required to provide written permission from your parents or guardians, as per local laws and regulations.

2 initial assessment

An initial assessment will be conducted to confirm your diagnosis of moderate to severe plaque psoriasis. This includes evaluating the Psoriasis Area and Severity Index (PASI), the static Physician’s Global Assessment (sPGA), and the percentage of Body Surface Area (BSA) affected.

3 treatment period

You will receive the medication deucravacitinib in one of the following forms: 2 mg sachet, 1 mg sachet, 6 mg tablet, or 3 mg sachet. The medication is taken orally.

The dosage and frequency will be determined by the study team, and you will be required to take the medication as instructed for a specified duration.

4 monitoring and follow-up

Throughout the study, regular monitoring will be conducted to evaluate the pharmacokinetics (how the drug is processed in your body), efficacy (how well the drug works), and safety (any side effects).

You will have scheduled visits to assess your condition and any changes in your symptoms.

5 long-term extension (LTE) period

If you complete the initial treatment period, you may be eligible to participate in the optional long-term extension (LTE) period to further evaluate the safety and tolerability of the medication.

During this period, additional monitoring of growth, including body weight, height, and sexual maturation, will be conducted.

Who Can Join the Study?

Participants must be males and females aged 12 to under 18 years for Cohort 1 and 4 to under 12 years for Cohort 2.
Participants must have been diagnosed with stable moderate to severe plaque psoriasis. This means no major changes in the disease for the past 6 months. The severity is measured by:
- Psoriasis Area and Severity Index (PASI) score of 12 or higher.
- Static Physician’s Global Assessment (sPGA) score of 3 or higher.
- Body Surface Area (BSA) with 10% or more affected.
Participants should be candidates for phototherapy (light treatment) or systemic therapy (medication that works throughout the body).
Participants must be willing to join the optional Long-Term Extension (LTE) period of the study.
Participants must be able to sign the Informed Consent Form (ICF) or give assent, which means agreeing to participate, according to local laws.
Written permission from parents, guardians, or legally acceptable representatives must be obtained according to local laws.
Participants must have completed the Week 52 treatment period in Part A or B of the study.

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.
Patients who are not within the age range of 4 to 18 years cannot participate.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other significant health issues that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who are allergic to the study medication or its ingredients cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny	Cracow	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Hospital Universitario De Cruces	Barakaldo	Spain
Centre Hospitalier Universitaire De Nice	Nice	France
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH	Hamburg	Germany
Policlinica CCBR S.R.L.	Bucharest	Romania
Lotus Med S.R.L.	Bucharest	Romania
Hospital General Universitario De Alicante	Alicante	Spain
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi	Iasi	Romania
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Spitalul Clinic Judetean Mures	Targu Mures	Romania
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Cowqnn Havjnulshng Uwvbioxbykupj Dj Dwzld	Dijon	France
Psalhrqkj Ijsararz Mtniufjc Miltbzjtycyy Sbzin Wgfpodfafctw I Alykmtqebuyzk	Warsaw	Poland
Cipjdm Hixsdaszazc Dn Jgwo Edrc Tmodlq	Calais	France
Uqtmninjuaigaunatnmqp Mtqsurip Aqp	Munster	Germany
Fwccsgmci Pvvd Lk Impxxiwmasqnl Bocqgitdh Din Htgltjvx Uarvmegjzumor Lx Pao	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.02.2021
Germany	Recruiting	05.02.2021
Poland	Recruiting	05.02.2021
Romania	Recruiting	05.02.2021
Spain	Recruiting	05.02.2021

Trial locations

Investigated drugs:

Deucravacitinib

Deucravacitinib is a medication being studied for its effects on children and teenagers with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. This medication works by targeting specific pathways in the immune system that are involved in the development of psoriasis. The goal of the trial is to understand how the body processes the medication, how effective it is in improving the skin condition, and how safe it is for use in young patients. Participants in the trial are divided into different age groups to see how the medication works in each group. The study aims to provide a better understanding of how this medication can help manage psoriasis in children and teenagers.

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:

2022-502519-13-00

Protocol code:

IM011-126

NCT ID:

NCT04772079

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Deucravacitinib for Children with Moderate to Severe Plaque Psoriasis

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