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NCT Number: NCT06979453

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

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

Recruiting

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Neumonologia Y Dermatologia, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Other names: BMS-986165

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)

    Time frame: At week 16

  2. Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline

    Time frame: At week 16

Secondary outcomes

  1. Number of participants achieving at least 90% improvement in PASI (PASI 90)

    Time frame: At week 16

  2. Change from baseline in PASI

    Time frame: At week 16

  3. Change from baseline in body surface area (BSA) involvement

    Time frame: At week 16

  4. Change from baseline in worst itch numeric rating scale (WI-NRS)

    Time frame: At week 16

  5. Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)

    Time frame: At week 16

  6. Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score

    Time frame: At week 16

  7. Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)

    Time frame: At week 16

  8. Number of participants with treatment emergent adverse events

    Time frame: Up to 5 years

  9. Number of participants with serious adverse events

    Time frame: Up to 5 years

  10. Number of participants with clinically significant changes in laboratory parameters

    Time frame: Up to 5 years

  11. Number of participants with clinically significant changes in physical examinations

    Time frame: Up to 5 years

  12. Number of participants with clinically significant changes in vital signs

    Time frame: Up to 5 years

  13. Number of participants with protective titers of antibodies to measles

    Time frame: At week 16

  14. Number of participants with protective titers of antibodies to tetanus

    Time frame: At week 16

  15. Number of participants with protective titers of antibodies to pertussis

    Time frame: At week 16

  16. Body weight

    Time frame: Up to 5 years

  17. Height

    Time frame: Up to 5 years

  18. Sexual maturation

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: POETYK-PsO-Ped

Important dates

Study start
2025
Primary completion
2029
Study completion
2034
First posted
May 20, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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