Actively Recruiting

Phase 3
Age: 12Years - 17Years
All Genders
ID06979453

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescents With Moderate to Severe Plaque Psoriasis

Led by Bristol-Myers Squibb · Updated on 2026-05-28

366

Participants Needed

123

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescents aged 12 to 17 years with moderate to severe plaque psoriasis. This is a randomized, double-blind, placebo-controlled Phase 3 study sponsored by Bristol-Myers Squibb. The study focuses on improving psoriasis symptoms and assessing overall treatment impact in this younger population. Participants will receive either Deucravacitinib or a placebo at specified doses on certain days. The study includes a treatment period of at least 16 weeks during which drug effects will be monitored closely. The trial measures improvements in psoriasis severity, body surface area affected, itch severity, and quality of life. Long-term safety and other health parameters will be followed for up to five years. During the study, participants will undergo regular assessments including clinical evaluations of psoriasis severity using the Psoriasis Area and Severity Index and the static Physicians Global Assessment. They will also complete questionnaires related to quality of life and itch symptoms. Blood tests will monitor drug levels and antibody protection to certain vaccines. Safety monitoring will include tracking adverse events, laboratory tests, physical exams, weight, height, and sexual maturation over several years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have stable plaque psoriasis for 6 months or more before screening.
  • Participants must have moderate to severe psoriasis defined by PASI score of 12 or higher at screening and Day 1.
  • Participants must have a static Physician's Global Assessment score of 3 or higher at screening and Day 1.
  • Participants must have at least 10% body surface area involvement at screening and Day 1.
  • Female participants assigned at birth must not be pregnant or breastfeeding.
  • Female participants who can have children must use a highly effective contraceptive method during the study and for 3 days after stopping treatment and agree not to donate eggs during that time.
Not Eligible

You will not qualify if you...

  • Participants must weigh at least 30.0 kg at screening and Day 1.
  • Participants must not have non-plaque psoriasis or other skin conditions that interfere with treatment assessment.
  • Participants must not have had serious infections requiring hospitalization and IV antimicrobial treatment within 60 days before Day 1.
  • Participants must not have untreated bacterial infections within 60 days prior to Day 1.
  • Participants must not have ongoing chronic bacterial infections.
  • Participants must not have herpes simplex/zoster, active tuberculosis, hepatitis B or C, or HIV.
  • Participants must not have received live vaccines or BCG within 60 days before Day 1 or plan to receive live vaccines during or soon after the study.
  • Participants must not have used Deucravacitinib before.
  • Participants must not have taken any prohibited medications.
  • Participants must not have exclusionary laboratory findings.
  • Participants must not have serious or unstable medical conditions increasing study risk.
  • Participants must not have cancer or lymphoproliferative disease in the past 5 years.
  • Other protocol-defined inclusion/exclusion criteria apply.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 16 weeks

Participants receive Deucravacitinib or placebo as part of the study treatment.

Trial Site Locations

Total: 123 locations

1

Local Institution - 0261

Birmingham, Alabama, United States, 35203

Not Yet Recruiting

2

Local Institution - 0041

Birmingham, Alabama, United States, 35243

Not Yet Recruiting

3

Local Institution - 0053

Phoenix, Arizona, United States, 85006

Active, Not Recruiting

4

Local Institution - 0025

Fountain Valley, California, United States, 92708

Not Yet Recruiting

5

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States, 94538

Actively Recruiting

6

Dermatology Research Associates

Los Angeles, California, United States, 90045

Actively Recruiting

7

Northridge Clinical Trials

Northridge, California, United States, 91325

Actively Recruiting

8

Local Institution - 0077

Sacramento, California, United States, 95814

Not Yet Recruiting

9

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

Walnut Creek, California, United States, 94598

Actively Recruiting

10

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, United States, 80033

Actively Recruiting

11

Local Institution - 0021

Clearwater, Florida, United States, 33756

Not Yet Recruiting

12

Life Clinical Trials

Margate, Florida, United States, 33063

Actively Recruiting

13

Skin Research of South Florida

Miami, Florida, United States, 33173

Actively Recruiting

14

Wellness Clinical Research

Miami Lakes, Florida, United States, 33016

Actively Recruiting

15

MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

Tampa, Florida, United States, 33607

Actively Recruiting

16

USF Health

Tampa, Florida, United States, 33612

Actively Recruiting

17

Dermatology Affiliates Research Institute

Atlanta, Georgia, United States, 30305

Actively Recruiting

18

Advanced Medical Research, PC.

Sandy Springs, Georgia, United States, 30328

Actively Recruiting

19

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Actively Recruiting

20

Local Institution - 0262

Murray, Kentucky, United States, 42071

Not Yet Recruiting

21

Local Institution - 0202

Metairie, Louisiana, United States, 70001

Not Yet Recruiting

22

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States, 20850

Actively Recruiting

23

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, United States, 01757

Actively Recruiting

24

Local Institution - 0095

Detroit, Michigan, United States, 48201

Not Yet Recruiting

25

Local Institution - 0233

Columbia, Missouri, United States, 65201

Not Yet Recruiting

26

Local Institution - 0266

Lee's Summit, Missouri, United States, 64064

Not Yet Recruiting

27

JDR Dermatology Research

Las Vegas, Nevada, United States, 89148

Actively Recruiting

28

Local Institution - 0281

Robbinsville, New Jersey, United States, 08691

Not Yet Recruiting

29

Local Institution - 0166

The Bronx, New York, United States, 10467

Not Yet Recruiting

30

Local Institution - 0234

Hickory, North Carolina, United States, 28602

Completed

31

Apex Clinical Research Center - Canton

Canton, Ohio, United States, 44716

Actively Recruiting

32

Local Institution - 0271

Columbus, Ohio, United States, 43228

Not Yet Recruiting

33

Local Institution - 0275

Lorain, Ohio, United States, 44053

Not Yet Recruiting

34

Apex Clinical Research Center

Mayfield Heights, Ohio, United States, 44124

Actively Recruiting

35

Paddington Testing Company

Philadelphia, Pennsylvania, United States, 19103

Actively Recruiting

36

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee, United States, 37072

Actively Recruiting

37

Local Institution - 0248

Nashville, Tennessee, United States, 37205

Completed

38

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Actively Recruiting

39

Local Institution - 0280

Southlake, Texas, United States, 76092

Not Yet Recruiting

40

Local Institution - 0045

Norfolk, Virginia, United States, 23502

Not Yet Recruiting

41

Frontier Derm Partners

Mill Creek, Washington, United States, 98012

Actively Recruiting

42

Local Institution - 0264

Spokane, Washington, United States, 99204

Not Yet Recruiting

43

Local Institution - 0115

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

Not Yet Recruiting

44

Local Institution - 0119

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

Not Yet Recruiting

45

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL

Actively Recruiting

46

Local Institution - 0149

Buenos Aires, Argentina, 1012

Not Yet Recruiting

47

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina, 1181

Actively Recruiting

48

Hospital de Niños Dr. Ricardo Gutiérrez

Buenos Aires, Argentina, 1425

Actively Recruiting

49

Derma Internacional

Buenos Aires, Argentina, 1426

Actively Recruiting

50

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium, 1200

Actively Recruiting

51

Local Institution - 0210

Brussels, Bruxelles-Capitale, Région de, Belgium, 1200

Withdrawn

52

UZ Gent

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

53

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium, 4000

Actively Recruiting

54

Local Institution - 0137

Salvador, Estado de Bahia, Brazil, 41820-020

Not Yet Recruiting

55

Local Institution - 0182

Porto Alegre, Rio Grande do Sul, Brazil, 90035-903

Not Yet Recruiting

56

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil, 90560-032

Actively Recruiting

57

Local Institution - 0140

Barretos, São Paulo, Brazil, 14784400

Not Yet Recruiting

58

Local Institution - 0163

Ribeirão Preto, São Paulo, Brazil, 14051-140

Not Yet Recruiting

59

Local Institution - 0170

São Paulo, Brazil, 05403-000

Not Yet Recruiting

60

Alberta Dermasurgery Centre

Edmonton, Alberta, Canada, T6G 1C3

Actively Recruiting

61

Local Institution - 0164

Winnipeg, Manitoba, Canada, R3C 0N2

Not Yet Recruiting

62

Skincare Studio

St. John's, Newfoundland and Labrador, Canada, A1E 1V4

Actively Recruiting

63

DermEffects

London, Ontario, Canada, N6H 5L5

Actively Recruiting

64

The Centre for Dermatology

Richmond Hill, Ontario, Canada, L4B 1A5

Actively Recruiting

65

AvantDerm

Toronto, Ontario, Canada, M5A 3R6

Actively Recruiting

66

Local Institution - 0240

Toronto, Ontario, Canada, M5G 1X8

Not Yet Recruiting

67

Local Institution - 0142

Montreal, Quebec, Canada, H3T 1C5

Not Yet Recruiting

68

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100045

Actively Recruiting

69

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100091

Actively Recruiting

70

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China, 518053

Actively Recruiting

71

The Affiliated Hospital of Hebei University of Engineering

Handan, Hebei, China, 56029

Actively Recruiting

72

Local Institution - 0227

Zhengzhou, Henan, China, 450003

Not Yet Recruiting

73

Hunan Children's Hospital

Changsha, Hunan, China, 410007

Actively Recruiting

74

Local Institution - 0265

Jinan, Shandong, China, 250022

Not Yet Recruiting

75

Local Institution - 0131

Shanghai, Shanghai Municipality, China, 200443

Not Yet Recruiting

76

Local Institution - 0228

Chengdu, Sichuan, China, 610091

Not Yet Recruiting

77

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

78

Local Institution - 0225

Medellín, Antioquia, Colombia, 050012

Not Yet Recruiting

79

Local Institution - 0124

Medellín, Antioquia, Colombia, 50021

Not Yet Recruiting

80

Local Institution - 0167

Barranquilla, Atlántico, Colombia, 080002

Not Yet Recruiting

81

Local Institution - 0125

Bogota, Cundinamarca, Colombia, 111 411

Not Yet Recruiting

82

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

83

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate, Germany, 55128

Actively Recruiting

84

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany, 10117

Actively Recruiting

85

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Actively Recruiting

86

Universitaetsklinikum Erlangen

Erlangen, Germany, 91054

Actively Recruiting

87

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, Hungary, 6720

Actively Recruiting

88

Clinexpert Kft.

Budapest, Pest County, Hungary, 1033

Actively Recruiting

89

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Actively Recruiting

90

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Actively Recruiting

91

Local Institution - 0238

Zapopan, Jalisco, Mexico, 45190

Not Yet Recruiting

92

Local Institution - 0253

Mexico City, Mexico City, Mexico, 06720

Not Yet Recruiting

93

Local Institution - 0155

Monterrey, Nuevo León, Mexico, 64718

Not Yet Recruiting

94

Local Institution - 0259

Chihuahua City, Mexico, 31217

Not Yet Recruiting

95

Local Institution - 0257

Mérida, Mexico, 97070

Not Yet Recruiting

96

Local Institution - 0258

Toluca, Mexico, 50010

Not Yet Recruiting

97

Local Institution - 0096

Veracruz, Mexico, 91910

Not Yet Recruiting

98

Local Institution - 0177

Lublin, Lublin Voivodeship, Poland, 20-573

Withdrawn

99

FutureMeds - Targowek

Warsaw, Masovian Voivodeship, Poland, 03-291

Actively Recruiting

100

SPECDERM Poznanska sp.j.

Bialystok, Podlaskie Voivodeship, Poland, 15-375

Actively Recruiting

101

Local Institution - 0282

Gdansk, Pomeranian Voivodeship, Poland, 80-546

Not Yet Recruiting

102

"DERMED" Centrum Medyczne Sp. z o.o.

Lodz, Poland, 90-265

Actively Recruiting

103

ETYKA Osrodek Badan Klinicznych

Olsztyn, Poland, 10-117

Actively Recruiting

104

Klinika Ambroziak Dermatologia

Warsaw, Poland, 02-953

Actively Recruiting

105

Royalderm Agnieszka Nawrocka

Warsaw, Poland, 02-962

Actively Recruiting

106

Local Institution - 0254

Bayamón, Puerto Rico, 00960

Not Yet Recruiting

107

Local Institution - 0008

Caguas, Puerto Rico, 00725

Not Yet Recruiting

108

GCM Medical Group, PSC - Hato Rey Site

San Juan, Puerto Rico, 00917

Actively Recruiting

109

Local Institution - 0174

Bucharest, Bucharest, Romania, 020125

Withdrawn

110

Lotus-Med Tunari

Bucharest, Bucharest, Romania, 020528

Actively Recruiting

111

Local Institution - 0213

Bucharest, Bucharest, Romania, 30463

Withdrawn

112

Policlinica Providența

Iași, Romania, 700259

Actively Recruiting

113

Centrul de Medicina de Familie

Iași, Romania, 700556

Actively Recruiting

114

New Derm Clinical SRL

Timișoara, Romania, 300757

Actively Recruiting

115

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950

Actively Recruiting

116

Local Institution - 0198

Barcelona, Catalunya [Cataluña], Spain, 08041

Not Yet Recruiting

117

Grupo Dermatológico y Estético Pedro Jaén S.A

Madrid, Spain, 28002

Actively Recruiting

118

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

119

CHUS - Hospital Clinico Universitario

Santiago de Compostela, Spain, 15706

Actively Recruiting

120

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301

Actively Recruiting

121

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, 81362

Actively Recruiting

122

National Taiwan University Hospital

Taipei, Taiwan, 10002

Actively Recruiting

123

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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