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Taking people in ItalyPhase 3

Tests deucravacitinib for skin patches in teens with psoriasis

Tests deucravacitinib against placebo in teens with moderate to severe plaque psoriasis.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Bologna and Rome, ItalySee the 3 sitesAlso in 15 other countries, 128 sites
Trial code
Registry title
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
People taking part
366 people, planned
Started
3 Dec 2025
Expected to end
12 Aug 2034
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Deucravacitinib
  • Placebo
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adolescents aged 12 to 17 years with moderate to severe plaque psoriasis that has been stable for at least 6 months.

Age
12 to 17 years (12 years to less than 18 years).
Sex
All sexes can join.
Disease stage
Stable plaque psoriasis for 6 months or more, moderate to severe: PASI 12 or higher, sPGA 3 or higher, and at least 10% of body surface involved.
Earlier treatment
People who have had deucravacitinib before cannot join. Live vaccines or BCG within 60 days before Day 1 are not allowed.

Main reasons for not taking part

  • Weight under 30.0 kg (66 lb)
  • Psoriasis types other than plaque psoriasis, such as guttate, inverse, pustular or erythrodermic
  • Serious or untreated bacterial, fungal or viral infection, or chronic bacterial infection
  • Active tuberculosis, hepatitis B, hepatitis C or HIV infection-related exclusions
  • Cancer or history of cancer within the previous 5 years

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Participants must have stable plaque psoriasis for 6 months or more prior to Screening
  • Participants must have moderate to severe psoriasis defined by:; Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1
  • Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1
  • Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1
  • A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
  • Is not an individual of childbearing potential (IOCBP)
  • Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period

Who cannot take part

  • Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1
  • Participants must not have any untreated bacterial infection within 60 days prior to Day 1
  • Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention
  • Participants must not have had any prior exposure to deucravacitinib
  • Participants must not have received any medication that is specifically prohibited
  • Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1
  • Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)
  • Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions
  • Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study
  • Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years
  • Participants must not have a laboratory finding that is exclusionary
  • Participants must not weigh < 30.0 kg at Screening and Day 1
  • Other protocol-defined Inclusion/Exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 17 years old?

Where in Italy

Also in 15 other countries, 128 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Università Cattolica del Sacro CuoreRome, ItalyTaking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

The 2 groups in the trial

  • Administration of DeucravacitinibExisting treatment, for comparison

    Treatment: Deucravacitinib

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis
Plain-language title
Tests deucravacitinib for skin patches in teens with psoriasisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06979453, who can take part
Record updated
27 October 2026