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Deucravacitinib for teens with moderate to severe plaque psoriasis

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

Phase 3 Interventional Bristol-Myers Squibb · NCT06979453

This trial will test whether deucravacitinib helps teens with moderate to severe plaque psoriasis while tracking safety and drug levels.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment366 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsdeucravacitinib
Locations120 sites (Birmingham, Alabama and 119 other locations)
Trial IDNCT06979453 on ClinicalTrials.gov

What this trial studies

Adolescent participants with stable moderate to severe plaque psoriasis who meet entry thresholds (PASI ≥12, sPGA ≥3, BSA ≥10%) will be enrolled and assigned to receive deucravacitinib or a matching placebo. The study will collect clinical measures of skin disease, safety data, and blood drug levels over the treatment period. Key outcome measures include changes in PASI, sPGA, and BSA from baseline as well as adverse events and laboratory monitoring. The protocol includes contraception and pregnancy-related requirements for participants who are of childbearing potential.

Who should consider this trial

Good fit: Teens with stable moderate to severe plaque psoriasis for at least six months who meet PASI ≥12, sPGA ≥3, and BSA ≥10% at screening and Day 1 and who meet the study's pregnancy/contraception requirements are ideal candidates.

Not a fit: Patients with mild disease, non-plaque psoriasis types, or those who are pregnant or breastfeeding (and therefore ineligible) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could offer an effective oral treatment that clears skin and reduces itch for teenagers with moderate to severe plaque psoriasis.

How similar studies have performed: Phase 3 trials in adults have shown deucravacitinib can improve plaque psoriasis, but efficacy and safety data in adolescents remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
* Participants must have moderate to severe psoriasis defined by:.

  i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.

ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.

iii) 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:.

i) Is not an individual of childbearing potential (IOCBP).

ii) 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.

Exclusion Criteria

* Participants must not weigh \< 30.0 kg at Screening and Day 1.
* 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 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 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 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 a laboratory finding that is exclusionary.
* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 119 other locations

+70 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plaque PsoriasisPsoriasisRashItchTeenDermatologyDermPOETYK-PsO-Peds-1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.