Actively Recruiting

Phase 3
Age: 4Years - 18Years
All Genders
NCT04772079

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

Led by Bristol-Myers Squibb · Updated on 2025-09-25

153

Participants Needed

63

Research Sites

650 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric 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 pediatric 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 pediatric participants with psoriasis who have completed Parts A or B of the study.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 12 to under 18 years for Cohort 1 and aged 4 to under 12 years for Cohort 2
  • Diagnosed with plaque psoriasis for at least 6 months
  • Have moderate to severe plaque psoriasis
  • Suitable candidates for phototherapy or systemic treatment
  • Completed Week 52 treatment in Part A or B to join the long-term extension period
Not Eligible

You will not qualify if you...

  • Participants weighing 30.0 kg or less in Cohort 1 (ages 12 to under 18 years) during Part A and Part B
  • Participants weighing 18.0 kg or less in Cohort 2 (ages 4 to under 12 years) during Part A and Part B
  • Having other types of psoriasis besides plaque psoriasis
  • History of recent infections
  • Previous use of deucravacitinib or an active comparator
  • Evidence of active tuberculosis during the long-term extension period
  • Other protocol-defined criteria may also exclude participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 63 locations

1

Instituto de Neumonologia Y Dermatologia

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425

Actively Recruiting

2

Psoriahue

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKG

Actively Recruiting

3

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina, 1012

Actively Recruiting

4

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina, C1056ABI

Actively Recruiting

5

Hospital Italiano de Buenos Aires

CABA, Argentina, 1199

Actively Recruiting

6

Consultora Integral de Salud

Córdoba, Argentina, 5004

Actively Recruiting

7

The Skin Hospital

Darlinghurst, New South Wales, Australia, 2010

Actively Recruiting

8

Local Institution - 0002

Westmead, New South Wales, Australia, 2145

Withdrawn

9

Queensland Children's Hospital

Brisbane, Queensland, Australia, 4101

Actively Recruiting

10

Veracity Clinical Research

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

11

Monash Health

Clayton, Victoria, Australia, 3168

Actively Recruiting

12

Local Institution - 0001

Melbourne, Victoria, Australia, 3995

Completed

13

Centro de Pesquisas da Clínica IBIS

Salvador, Estado de Bahia, Brazil, 41820-020

Actively Recruiting

14

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil, 90560032

Actively Recruiting

15

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP

Ribeirão Preto, São Paulo, Brazil, 14051-140

Actively Recruiting

16

Local Institution - 0083

Rio de Janeiro, Brazil, 22470-220

Not Yet Recruiting

17

Local Institution - 0067

São Paulo, Brazil, 05403-000

Withdrawn

18

Local Institution - 0010

Calgary, Alberta, Canada, T2J 7E1

Completed

19

Alberta Dermasurgery Centre

Edmonton, Alberta, Canada, T6G 1C3

Actively Recruiting

20

Local Institution - 0039

Hamilton, Ontario, Canada, L8N 1Y2

Withdrawn

21

Lynderm Research Inc.

Markham, Ontario, Canada, L3P 1X3

Actively Recruiting

22

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

23

Centre Hospitalier de Calais

Calais, France, 62107

Actively Recruiting

24

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology

Dijon, France, 21000

Actively Recruiting

25

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, France, 06202

Actively Recruiting

26

Local Institution - 0021

Paris, France, 75019

Completed

27

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

28

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, Germany, 55131

Actively Recruiting

29

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, Germany, 01307

Actively Recruiting

30

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany, 10117

Actively Recruiting

31

Kath. Kinderkrankenhaus Wilhelmstift

Hamburg, Germany, 22149

Actively Recruiting

32

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan, 467-8602

Actively Recruiting

33

Fukuoka University Hospital

Fukuoka, Jonan-Ku, Fukuoka, Japan, 814-0180

Actively Recruiting

34

Local Institution - 0040

Isehara, Kanagawa, Japan, 259-1193

Withdrawn

35

Mie University Hospital

Tsu, Mie-ken, Japan, 514-8507

Actively Recruiting

36

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan, 173-8606

Actively Recruiting

37

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan, 160-0023

Actively Recruiting

38

Nippon Life Hospital

Osaka, Japan, 550-0006

Actively Recruiting

39

Crea de Guadalajara

Guadalajara, Jalisco, Mexico, 44600

Actively Recruiting

40

Grupo Clínico CATEI S.C.

Guadalajara, Jalisco, Mexico, 44638

Actively Recruiting

41

RM Pharma Specialists

Mexico City, Mexico City, Mexico, 03100

Actively Recruiting

42

Arké SMO S.A de C.V

Veracruz, Mexico, 91910

Actively Recruiting

43

Local Institution - 0011

Krakow, Poland, 30-438

Completed

44

Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Poland, 90-436

Actively Recruiting

45

Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii

Warsaw, Poland, 02-507

Actively Recruiting

46

WroMedica

Wroclaw, Poland, 51-620

Actively Recruiting

47

Local Institution - 0080

Bucharest, Bucharest, Romania, 012292

Withdrawn

48

Local Institution - 0081

Bucharest, Bucharest, Romania, 020125

Withdrawn

49

Local Institution - 0088

Bucharest, Bucharest, Romania, 020762

Withdrawn

50

CCBR Clinical Research

Bucharest, Bucharest, Romania, 30463

Actively Recruiting

51

Lotus-Med Tunari

Bucharest, Romania, 020528

Actively Recruiting

52

Spitalul clinic de urgenta pentru copii Sf. Maria

Iași, Romania, 700309

Actively Recruiting

53

Spitalul Clinic Judetean Mures

Târgu Mureş, Romania, 540342

Actively Recruiting

54

Local Institution - 0048

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02447

Completed

55

Local Institution - 0047

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722

Completed

56

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591

Actively Recruiting

57

Hospital General Universitario de Alicante-Dermatology

Alicante, Spain, 03010

Actively Recruiting

58

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology

Barakaldo, Spain, 48903

Actively Recruiting

59

Hospital Sant Joan de Déu-URC Dermatology

Esplugues de Llobregat, Spain, 08950

Actively Recruiting

60

Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología

Las Palmas de GC, Spain, 35019

Actively Recruiting

61

Hospital Universitario 12 de Octubre-DERMATOLOGY

Madrid, Spain, 28041

Actively Recruiting

62

Hospital Universitario La Paz-UCICEC/DERMA

Madrid, Spain, 28046

Actively Recruiting

63

Mounts Bay Medical

Connor Downs, United Kingdom, TR27 5DT

Actively Recruiting

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Research Team

B

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

F

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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