Study on Bimekizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying the effects of two treatments for moderate to severe plaque psoriasis in children and teenagers aged 6 to less than 18 years. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. The study will compare the effectiveness and safety of two medications: bimekizumab and ustekinumab. Bimekizumab, also known by its code name UCB4940, and ustekinumab are both given as a solution for injection under the skin.

The purpose of the study is to evaluate how well bimekizumab works compared to ustekinumab in treating children and adolescents with this condition. Participants will receive either bimekizumab, ustekinumab, or a placebo, which is a substance with no active medication. The study will last for a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any side effects.

Throughout the study, doctors will assess the improvement in the skin condition using specific measures, such as the Psoriasis Area and Severity Index (PASI) and the Investigator’s Global Assessment (IGA). These assessments will help determine the effectiveness of the treatments. The study will also monitor any changes in the participants’ overall health, including growth and quality of life, to ensure the safety of the treatments being tested.

1 initial treatment period

During this period, the participant will receive either bimekizumab or ustekinumab through subcutaneous injections. The specific dosage and frequency will be determined by the study protocol.

The primary goal is to assess the effectiveness of the treatment by measuring the improvement in skin condition using the Psoriasis Area Severity Index (PASI) and the Investigator’s Global Assessment (IGA) at Week 16.

2 maintenance period

Following the initial treatment period, the participant will continue to receive the assigned treatment to maintain the improvements achieved.

The participant’s response will be monitored at various intervals, including Week 48, to evaluate long-term effectiveness and safety.

3 safety and efficacy assessments

Throughout the trial, regular assessments will be conducted to monitor the participant’s health and the treatment’s impact. This includes checking for any adverse effects and changes in vital signs, physical examination findings, and laboratory results.

The participant’s quality of life and any changes in symptoms will also be evaluated using specific questionnaires and scales.

4 end of study evaluations

At the conclusion of the study, final assessments will be performed to determine the overall effectiveness and safety of the treatment.

The participant’s progress and any long-term effects of the treatment will be documented and analyzed.

Who Can Join the Study?

The participant must be between 6 and less than 18 years old at the time of signing the consent form.
The participant must have been diagnosed with moderate to severe plaque psoriasis for at least 3 months before the screening visit. Plaque psoriasis is a skin condition that causes red, scaly patches.
At both the screening and baseline visits, the participant must have:
- Body surface area (BSA) affected by psoriasis of 10% or more. This means that at least 10% of the skin is affected by psoriasis.
- An Investigator’s Global Assessment (IGA) score of 3 or more on a scale from 0 to 4. This score helps to measure the severity of psoriasis.
- A Psoriasis Area and Severity Index (PASI) score of 12 or more, or a PASI score of 10 or more with at least one of the following:
  - Significant involvement of the face.
  - Significant involvement of the genital area.
  - Significant involvement of the hands and feet.
The participant must be eligible for systemic psoriasis therapy, which involves medication that affects the whole body, and/or phototherapy or chemotherapy, as well as treatment with ustekinumab, according to its guidelines.
The participant must weigh at least 15 kg and have a body mass index (BMI) for their age in the 5th percentile or higher at the screening. BMI is a measure that uses height and weight to estimate body fat.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have received certain vaccines recently.
Patients who have a history of drug or alcohol abuse.
Patients who have certain blood disorders.
Patients who have a weakened immune system.
Patients who have had a recent surgery.
Patients who have certain skin conditions other than psoriasis.
Patients who have a history of cancer.
Patients who have liver or kidney problems.
Patients who have uncontrolled high blood pressure.
Patients who have heart problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland

Other Sites

Site Name	City	Country
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cglutegxw Ujvrchjdfyadiy Svwluyvvq	Woluwe-Saint-Lambert	Belgium
Csrjod Htpttusfkpc Vridnl Djnuqx	Argenteuil	France
Uuzcfvhyfe Oj Dypqxhso	Debrecen	Hungary
Ciemtgfwni Pxrjgdqcqee Ldruvxkjavdbidozlgqfqlr Mtrndssq szome	Wroclaw	Poland
Uszgdawdhvmonlwrwbxyi Eitvycfw Aln	Erlangen	Germany
Cshplln Uoepiiqiiattxzabjsek Bjijww Ktp	Berlin	Germany
Uwzysmmvdisoafmtm Pwkeniffean Dxgvg Msruoc	Ancona	Italy
Udqdxoucttrt Dn Ssiwowbe Dy Cgrgicfsuc	Santiago De Compostela	Spain
Utwoauebuqtjzysqpjwam Mpteyejn Ayk	Munster	Germany
Uvddpbiipk Ov Sgdvyb	Szeged	Hungary
Hotyzkqm Ds Ld Sjegn Ctwu I Snfq Prc	Barcelona	Spain
Cytsox hsifzoldqda utvefwhzsgffm df Lzfbf	Liege	Belgium
Hzkoqgwi Szfj Jxai De Dwt Boszixpfi	Esplugues De Llobregat	Spain
Uuhcggqmukncmrrowzdgu Slhyfcmymusyhumrvp Afj	Kiel	Germany
Hkseeyuw Urhjwccvdzvxs Vrhltj Dz Lke Naqjuy	Granada	Spain
Aciwjic Oowznjsehdk Uaphqoiwfccmf Pkmwza	Pisa	Italy
Fftdaxyv Nqavjovsh Pazpo	Plzen	Czechia
Ammbuof Ofzprcyudyadvvmzqojwotinv Pqunvxhkroo Gt Rejwsskvidgt Mrcmf Du Cfrzzqg	Catania	Italy
Ueschnjpdkyeq Saebyxz Kycftqnea Iqekfntaghnk Ciholjo W Rkceexqle	Rzeszow	Poland
Sveovh Vwjhngydg Kckqgd Mse Odqlia Kxvsxd	Kaposvar	Hungary
Kwyqmynuuorm Kmbftoinhrtjlfiji Wdjctwenncdi glezn	Hamburg	Germany
Gdtfqp Uezzelnvsw Fuwjdbtif	Frankfurt	Germany
Dfomlilvep Spb z oagb	Wroclaw	Poland
Wfehtlznhh Sxibcwtfpmwetbo Sodzncf Iw Dh Ww Bnpxqpcvwuyt	Lodz	Poland
Tnvvy Pewjgnkxxnt Srhsmjpwzjgb Cnolkis Mwamsrau Sun z ohky	Szczecin	Poland
Tbnrgqculhx uci Stdkbfvuilt Bmapfbxl Gpir	Bad Bentheim	Germany
Tjxcq Pihmhmmfodd Nwlbauvxctj Cgshdms Mdlpnxkh Six z osku	Nowa Sol	Poland
Rotmc Caqtqa Sms z ozul	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.07.2024
Czechia	Not recruiting	31.07.2024
France	Not recruiting	31.07.2024
Germany	Not recruiting	31.07.2024
Hungary	Not recruiting	31.07.2024
Italy	Not recruiting	31.07.2024
Poland	Not recruiting	31.07.2024
Spain	Not recruiting	31.07.2024

Trial locations

Investigated Drugs:

Bimekizumab is a medication being studied for its effectiveness in treating moderate to severe plaque psoriasis in children and adolescents. It is given as an injection under the skin. The goal is to see how well it works in reducing the symptoms of psoriasis, which is a skin condition that causes red, scaly patches.

Ustekinumab is another medication used in this study as a comparison to bimekizumab. It is also used to treat moderate to severe plaque psoriasis and is administered through an injection. The study aims to compare the effectiveness and safety of ustekinumab with bimekizumab in managing psoriasis symptoms in young patients.

Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by red, scaly patches that can appear anywhere on the body. The patches, known as plaques, are often itchy and can be painful. The disease occurs when skin cells multiply faster than normal, leading to a buildup of cells on the skin’s surface. It typically progresses with periods of flare-ups and remission. The severity can vary, with moderate to severe cases covering larger areas of the body and causing more significant discomfort. Environmental factors, stress, and certain medications can trigger or worsen the symptoms.

Trial ID:

2023-503859-10-00

Protocol code:

PS0021

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Bimekizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?