Study of deucravacitinib compared to placebo in adolescents aged 12-17 years with moderate to severe plaque psoriasis

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What is this study about?

This study focuses on evaluating a medication called deucravacitinib (also known as BMS-986165) for treating moderate to severe plaque psoriasis in young people between 12 and 18 years old. Plaque psoriasis is a skin condition that causes red, thick, scaly patches on the skin. The purpose of this research is to determine how well the medication works and how safe it is for adolescent patients.

The study will test deucravacitinib against placebo in participants who have had plaque psoriasis for at least 6 months and who could benefit from whole-body treatment. The medication comes in the form of film-coated tablets that are taken by mouth. During the study, researchers will monitor how the skin condition improves and track any changes in participants’ health.

The main focus will be on measuring improvements in the skin condition after 16 weeks of treatment. The study will also look at how the medication affects participants’ growth and development. Throughout the study, doctors will regularly check participants’ overall health, including their height, weight, and physical development.

1 Initial assessment and qualification

Your eligibility for the study will be evaluated if you are between 12 and 18 years old and have had moderate to severe plaque psoriasis for at least 6 months

The condition should be stable and require systemic treatment (medication that affects the entire body) or light therapy

2 Treatment phase – first 16 weeks

You will be randomly assigned to receive either deucravacitinib (active medication) or a placebo (inactive substance) in the form of oral tablets

The medication or placebo will be taken by mouth daily

Neither you nor your doctor will know whether you are receiving the actual medication or placebo

3 Evaluation at week 16

Your skin condition will be assessed using two main measurements:

The PASI score (a tool that measures the severity and area of psoriasis)

The sPGA score (a measurement of how clear your skin has become)

Blood tests will be performed to check antibody levels for measles, tetanus, and pertussis

Your growth, weight, and physical development will be monitored

4 Long-term extension phase

After the initial 16 weeks, the study continues with long-term monitoring

Regular assessments of your skin condition will continue

Ongoing monitoring of your growth, weight, and development

Regular safety checks including physical examinations and monitoring of vital signs

Who Can Join the Study?

  • Age between 12 and 17 years old
  • Must have had moderate to severe plaque psoriasis that has been stable for at least 6 months
  • Must be suitable for either:
    • Systemic therapy (medications that work throughout the entire body, usually taken as pills or injections)
    • Phototherapy (treatment using special ultraviolet light)
  • Both males and females can participate

Who Cannot Join the Study?

  • Age below 12 years or 18 years and above
  • Previous treatment with deucravacitinib (the study medication)
  • Active or chronic infections, including tuberculosis or hepatitis B or C
  • History of severe allergic reactions to medications
  • Current diagnosis of other forms of psoriasis besides plaque psoriasis
  • Significant heart, liver, or kidney problems
  • Active or recent cancer (within past 5 years)
  • Pregnancy or breastfeeding
  • Use of other medications for psoriasis that could interfere with the study
  • Mental health conditions that could affect participation in the study
  • Any condition that, in the opinion of the study doctor, would make it unsafe to participate
  • Unable to follow study procedures or attend scheduled visits
  • Participation in another clinical trial within the past 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Technische Universitaet Dresden Dresden Germany
Royalderm Agnieszka Nawrocka Warsaw Poland
Futuremeds Sp. z o.o. Wroclaw Poland
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland

Other Sites

Site Name City Country Status
Clinexpert Kft. Budapest Hungary
BAG Dres. med. Quist PartG Mainz Germany
Cwjqotjpc Uudiqvrxwptyeg Scxgxrrpo Woluwe-Saint-Lambert Belgium
Uxxqhvygta Ot Dsgumojl Debrecen Hungary
Ummiorwytwfbtrspzyauo Eulzhbuu Ace Erlangen Germany
Cxdrbui Urlvhcllkqhviunuucvh Bcqpkn Kiz Berlin Germany
Ugrgmfhszaeo Dk Stswggor Dv Cdramedhkv Santiago De Compostela Spain
Ukvovzivhqzjdgpxocxlx Madgjfwo Akc Munster Germany
Uqldxclqck Oh Sblvdu Szeged Hungary
Aqnayda Umvsg Swowmekoy Lcdctf Dv Bqkqofd Bologna Italy
Hssjjtov Dz Le Smtyq Csfd I Solr Pfe Barcelona Spain
Cdbpco hnvvavjxgqj usotyhzlhfeyb dk Lrtrf Liege Belgium
Usgqvawknaur Zoszgcijzx Gzxw Gent Belgium
Hrwvhizd Ubfhdxltsmsgj 1j Dp Oditbdm Madrid Spain
Kuhbbdh Akrsmjwqr Svi z oays Warsaw Poland
Szowfrxr Powtsusxc Sqa jr Bialystok Poland
Lpbeoiz Szijwrtgclmplpa Gryqyks Dhtrmmjdvkastzo Lublin Poland
Cbnggla db Mlwrvtza da Fvxkjbr Iasi Romania
Ncf Dfzl Cjjwbjyv Spl Timisoara Romania
Ls Cvtrjpsy Ccbguag Dpnhcrjeupfx i Ehxcuwnx Garwolin Poland
Utuzknpiwq Cnqphlpdl Dts Sixxx Cczsp Rome Italy
Eyidu Ojkvtux Bqqkp Kkiruaaeuft Tugxkz Pngzt Sxtoco Olsztyn Poland
Lksca Mvh Sbfoly Bucharest Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.09.2025
Germany Germany
Recruiting
01.09.2025
Hungary Hungary
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Poland Poland
Recruiting
01.09.2025
Romania Romania
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025

Trial locations

Investigated Drugs:

Deucravacitinib is a medication being studied for treating moderate to severe plaque psoriasis in adolescents. It works by targeting specific proteins in the immune system that are involved in causing inflammation and skin symptoms in psoriasis. This medication is taken orally and aims to reduce the severity of psoriasis plaques and improve the overall condition of the skin.

Placebo is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a comparison to determine how effective the actual treatment is.

Investigated Diseases:

Plaque Psoriasis – A chronic skin condition that causes cells to build up rapidly on the surface of the skin, forming thick, silvery scales and itchy, dry, red patches that can be painful. The patches most commonly appear on the knees, elbows, trunk, and scalp. The condition occurs when the immune system sends faulty signals, causing skin cells to grow too quickly. In moderate to severe cases, the patches can cover large areas of the body, with periods of flare-ups alternating with periods of remission. The condition can begin at any age but most often develops in adulthood.

Trial ID:
2023-506296-97-00
Protocol code:
IM011-1128
Trial Phase:
Therapeutic confirmatory (Phase III)

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