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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT06979453
Other Study ID Numbers:
IM011-1128
First Submitted
May 12, 2025
First Posted
May 19, 2025
Last Update Posted
April 29, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Plaque Psoriasis
Drug: DeucravacitinibOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment366 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateDecember 2, 2025
Actual Primary Completion Date3yrs 4mos from now
Actual Study Completion Date8yrs 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Administration of Deucravacitinib
Drug: Deucravacitinib
Specified dose on specified days
Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
  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
Secondary Outcome Measures
  1. Number of participants achieving at least 90% improvement in PASI (PASI 90)
  2. Change from baseline in PASI
  3. Change from baseline in body surface area (BSA) involvement
  4. Change from baseline in worst itch numeric rating scale (WI-NRS)
  5. Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)
  6. Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score
  7. Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)
  8. Number of participants with treatment emergent adverse events
  9. Number of participants with serious adverse events
  10. Number of participants with clinically significant changes in laboratory parameters
  11. Number of participants with clinically significant changes in physical examinations
  12. Number of participants with clinically significant changes in vital signs
  13. Number of participants with protective titers of antibodies to measles
  14. Number of participants with protective titers of antibodies to tetanus
  15. Number of participants with protective titers of antibodies to pertussis
  16. Body weight
  17. Height
  18. Sexual maturation

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0261 | Birmingham Alabama, United States, 35203Local Institution - 0041 | Birmingham Alabama, United States, 35243Local Institution - 0053 | Phoenix Arizona, United States, 85006Local Institution - 0025 | Fountain Valley California, United States, 92708Center For Dermatology Clinical Research, Inc. | Fremont California, United States, 94538Dermatology Research Associates | Los Angeles California, United States, 90045Northridge Clinical Trials | Northridge California, United States, 91325Local Institution - 0077 | Sacramento California, United States, 95814Golden State Dermatology - Walnut Creek - Ygnacio Valley Road | Walnut Creek California, United States, 94598Paradigm Clinical Research, LLC | Wheat Ridge Colorado, United States, 80033Local Institution - 0021 | Clearwater Florida, United States, 33756Life Clinical Trials | Margate Florida, United States, 33063Skin Research of South Florida | Miami Florida, United States, 33173Wellness Clinical Research | Miami Lakes Florida, United States, 33016MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research | Tampa Florida, United States, 33607USF Health | Tampa Florida, United States, 33612Dermatology Affiliates Research Institute | Atlanta Georgia, United States, 30305Advanced Medical Research, PC. | Sandy Springs Georgia, United States, 30328Dawes Fretzin Clinical Research Group, LLC | Indianapolis Indiana, United States, 46250Local Institution - 0262 | Murray Kentucky, United States, 42071Local Institution - 0202 | Metairie Louisiana, United States, 70001Dermatology and Skin Cancer Specialists, LLC | Rockville Maryland, United States, 20850Kuchnir Dermatology & Dermatologic Surgery | Milford Massachusetts, United States, 01757Local Institution - 0095 | Detroit Michigan, United States, 48201Local Institution - 0233 | Columbia Missouri, United States, 65201Local Institution - 0266 | Lee's Summit Missouri, United States, 64064JDR Dermatology Research | Las Vegas Nevada, United States, 89148Local Institution - 0166 | The Bronx New York, United States, 10467Local Institution - 0234 | Hickory North Carolina, United States, 28602Apex Clinical Research Center - Canton | Canton Ohio, United States, 44716Local Institution - 0271 | Columbus Ohio, United States, 43228Apex Clinical Research Center | Mayfield Heights Ohio, United States, 44124Paddington Testing Company | Philadelphia Pennsylvania, United States, 19103ObjectiveHealth - Goodlettsville Dermatology Research | Goodlettsville Tennessee, United States, 37072Local Institution - 0248 | Nashville Tennessee, United States, 37205Local Institution - 0268 | Austin Texas, United States, 78759Local Institution - 0267 | Cedar Park Texas, United States, 78613Texas Dermatology and Laser Specialists | San Antonio Texas, United States, 78218Local Institution - 0045 | Norfolk Virginia, United States, 23502Frontier Derm Partners | Mill Creek Washington, United States, 98012Local Institution - 0264 | Spokane Washington, United States, 99204Local Institution - 0115 | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, 1425Local Institution - 0119 | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1425DKGLocal Institution - 0149 | Buenos Aires , Argentina, 1012Local Institution - 0221 | Buenos Aires , Argentina, 1181Local Institution - 0250 | Buenos Aires , Argentina, 1425Local Institution - 0154 | Buenos Aires , Argentina, 1426Cliniques universitaires Saint-Luc | Brussels Bruxelles-Capitale, Région de, Belgium, 1200Local Institution - 0210 | Brussels Bruxelles-Capitale, Région de, Belgium, 1200UZ Gent | Ghent Oost-Vlaanderen, Belgium, 9000Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège , Belgium, 4000Local Institution - 0137 | Salvador Estado de Bahia, Brazil, 41820-020Local Institution - 0182 | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Local Institution - 0136 | Porto Alegre Rio Grande do Sul, Brazil, 90560-032Local Institution - 0140 | Barretos São Paulo, Brazil, 14784400Local Institution - 0163 | Ribeirão Preto São Paulo, Brazil, 14051-140Local Institution - 0170 | São Paulo , Brazil, 05403-000Alberta Dermasurgery Centre | Edmonton Alberta, Canada, T6G 1C3Local Institution - 0164 | Winnipeg Manitoba, Canada, R3C 0N2Skincare Studio | St. John's Newfoundland and Labrador, Canada, A1E 1V4DermEffects | London Ontario, Canada, N6H 5L5The Centre for Dermatology | Richmond Hill Ontario, Canada, L4B 1A5AvantDerm | Toronto Ontario, Canada, M5A 3R6Local Institution - 0240 | Toronto Ontario, Canada, M5G 1X8Local Institution - 0142 | Montreal Quebec, Canada, H3T 1C5Beijing Children's hospital, Capital Medical University | Beijing Beijing Municipality, China, 100045Peking University Third Hospital | Beijing Beijing Municipality, China, 100091The University of Hong Kong-Shenzhen Hospital | Shenzhen Guangdong, China, 518053The Affiliated Hospital of Hebei University of Engineering | Handan Hebei, China, 56029Local Institution - 0227 | Zhengzhou Henan, China, 450003Hunan Children's Hospital | Changsha Hunan, China, 410007Local Institution - 0265 | Jinan Shandong, China, 250022Local Institution - 0131 | Shanghai Shanghai Municipality, China, 200443Local Institution - 0228 | Chengdu Sichuan, China, 610091The First People's Hospital of Hangzhou | Hangzhou Zhejiang, China, 310006Local Institution - 0225 | Medellín Antioquia, Colombia, 050012Local Institution - 0124 | Medellín Antioquia, Colombia, 50021Local Institution - 0167 | Barranquilla Atlántico, Colombia, 080002Local Institution - 0125 | Bogota Cundinamarca, Colombia, 111 411Universitätsklinikum Münster | Münster North Rhine-Westphalia, Germany, 48149BAG Drs. Med. Quist PartG | Mainz Rhineland-Palatinate, Germany, 55128Charité Universitaetsmedizin Berlin - Campus Mitte | Berlin , Germany, 10117Universitaetsklinikum Carl Gustav Carus Dresden | Dresden , Germany, 01307Universitaetsklinikum Erlangen | Erlangen , Germany, 91054Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Szeged Csongrád megye, Hungary, 6720Clinexpert Kft. | Budapest Pest County, Hungary, 1033Debreceni Egyetem Klinikai Kozpont | Debrecen , Hungary, 4032Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Roma , Italy, 00168Local Institution - 0238 | Zapopan Jalisco, Mexico, 45190Local Institution - 0253 | Mexico City Mexico City, Mexico, 06720Local Institution - 0155 | Monterrey Nuevo León, Mexico, 64718Local Institution - 0259 | Chihuahua City , Mexico, 31217Local Institution - 0257 | Mérida , Mexico, 97070Local Institution - 0258 | Toluca , Mexico, 50010Local Institution - 0096 | Veracruz , Mexico, 91910Local Institution - 0177 | Lublin Lublin Voivodeship, Poland, 20-573FutureMeds - Targowek | Warsaw Masovian Voivodeship, Poland, 03-291SPECDERM Poznanska sp.j. | Bialystok Podlaskie Voivodeship, Poland, 15-375"DERMED" Centrum Medyczne Sp. z o.o. | Lodz , Poland, 90-265ETYKA Osrodek Badan Klinicznych | Olsztyn , Poland, 10-117Klinika Ambroziak Dermatologia | Warsaw , Poland, 02-953Royalderm Agnieszka Nawrocka | Warsaw , Poland, 02-962Local Institution - 0254 | Bayamón , Puerto Rico, 00960Local Institution - 0008 | Caguas , Puerto Rico, 00725GCM Medical Group, PSC - Hato Rey Site | San Juan , Puerto Rico, 00917Local Institution - 0174 | Bucharest Bucharest, Romania, 020125Lotus-Med Tunari | Bucharest Bucharest, Romania, 020528Local Institution - 0213 | Bucharest Bucharest, Romania, 30463Policlinica Providența | Iași , Romania, 700259Centrul de Medicina de Familie | Iași , Romania, 700556New Derm Clinical SRL | Timișoara , Romania, 300757Hospital Sant Joan de Déu | Esplugues de Llobregat Barcelona [Barcelona], Spain, 08950Local Institution - 0198 | Barcelona Catalunya [Cataluña], Spain, 08041Grupo Dermatológico y Estético Pedro Jaén S.A | Madrid , Spain, 28002Hospital Universitario 12 de Octubre | Madrid , Spain, 28041CHUS - Hospital Clinico Universitario | Santiago de Compostela , Spain, 15706Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist Kaohsiung, Taiwan, 83301Kaohsiung Veterans General Hospital | Kaohsiung City , Taiwan, 81362National Taiwan University Hospital | Taipei , Taiwan, 10002Chang Gung Medical Foundation-Linkou Branch | Taoyuan , Taiwan, 333
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb