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NCT Number: NCT04772079

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.

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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

4 year–18 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

  • Males and females aged 12 to <18 years for Cohort 1. Males and females aged 4 to <12 years for Cohort 2.
  • Plaque psoriasis for at least 6 months.
  • Moderate to severe disease.
  • Candidate for phototherapy or systemic therapy.
  • Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.

Exclusion criteria

  • Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing < 18.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B.
  • Other forms of psoriasis.
  • History of recent infection.
  • Prior exposure to deucravacitinib (BMS-986165) or another active comparator.
  • Evidence of active TB for LTE period.
  • Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Placebo matching deucravacitinib

Other

Specified dose on specified days

Primary outcomes

  1. Observed average concentration at steady state for deucravacitinib at Week 2

    Time frame: Week 2

    Part A

  2. Maximum observed plasma concentration at steady state for deucravacitinib at Week 2

    Time frame: Week 2

    Part A

  3. Trough observed plasma concentration for deucravacitinib at Week 2

    Time frame: Week 2

    Part A

  4. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16

    Time frame: Week 16

    Part B

  5. Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16

    Time frame: Week 16

    Part B

  6. Incidence of Adverse Events (AEs)

    Time frame: Up to 316 weeks

    Long-term extension (LTE) Period

  7. Incidence of serious adverse events (SAEs)

    Time frame: Up to 316 weeks

    LTE Period

  8. Monitoring of growth: Body weight

    Time frame: Up to 316 weeks

    LTE Period

  9. Monitoring of growth: Height

    Time frame: Up to 316 weeks

    LTE Period

  10. Monitoring of growth: Tanner staging (sexual maturation)

    Time frame: Up to 316 weeks

    LTE Period

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to Week 52

    Part A and Part B

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to Week 52

    Part A and Part B

  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to Week 52

    Part A and Part B

  4. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests

    Time frame: Up to Week 52

    Part A and Part B

  5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to Week 52

    Part A and Part B

  6. Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests

    Time frame: Up to Week 52

    Part A and Part B

  7. Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests

    Time frame: Up to Week 52

    Part A and Part B

  8. Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests

    Time frame: Up to Week 52

    Part A and Part B

  9. Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests

    Time frame: Up to Week 52

    Part A and Part B

  10. Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only

    Time frame: Up to Week 52

    Part A and Part B

  11. Incidence of clinically significant changes in lymphocyte subsets and function

    Time frame: Up to Week 52

    Part A and Part B

  12. Incidence of clinically significant changes in cytokine levels

    Time frame: Up to Week 52

    Part A and Part B

  13. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to Week 52

    Part A and Part B

  14. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to Week 52

    Part A and Part B

  15. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to Week 52

    Part A and Part B

  16. Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure

    Time frame: Up to Week 52

    Part A and Part B

  17. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to Week 52

    Part A and Part B

  18. Monitoring of growth: Body weight

    Time frame: Up to Week 52

    Part A and Part B

  19. Monitoring of growth: Height

    Time frame: Up to Week 52

    Part A and Part B

  20. Monitoring of growth: Tanner staging (sexual maturation)

    Time frame: Up to Week 52

    Part A and Part B

  21. Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  22. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  23. Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  24. Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  25. Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  26. Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  27. Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  28. Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  29. Proportion of subjects achieving Juvenile Idiopathic Arthritis and the American College of Rheumatology 30 (JIA-ACR 30) response at Week 16 for subjects with confirmed JPsA prior to baseline

    Time frame: Week 16

    Part B

    JIA-ACR 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo

  30. Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo

    Time frame: Week 16

    Part B

  31. Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16

    Time frame: Week 16

    Part B

  32. Observed average concentration at steady state for deucravacitinib at Week 16

    Time frame: Week 16

    Part B

  33. Maximum observed plasma concentration at steady state for deucravacitinib at Week 16

    Time frame: Week 16

    Part B

  34. Trough observed plasma concentration for deucravacitinib at Week 16

    Time frame: Week 16

    Part B

  35. Proportion of participants with 75% improvement in PASI (PASI 75) over time

    Time frame: Up to 316 weeks

    LTE Period

  36. Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time

    Time frame: Up to 316 weeks

    LTE Period

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 Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2021
Primary completion
2029
Study completion
2033
First posted
Feb 26, 2021
Registry last updated
Jun 9, 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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