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A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
NCT06979453 · Bristol-Myers Squibb
In plain English
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Official 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
About this study
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
Eligibility 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.
Study design
Enrollment target: 366 participants
Allocation: randomized
Masking: double
Age groups: child
Timeline
Starts: 2025-12-03
Estimated completion: 2034-08-12
Last updated: 2026-03-24
Interventions
Drug: DeucravacitinibOther: Placebo
Primary outcomes
- • Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) (At week 16)
- • 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 (At week 16)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (116)
Local Institution - 0261Not Yet Recruiting
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
Local Institution - 0053Active Not Recruiting
Phoenix, Arizona, United States
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Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.Recruiting
Fremont, California, United States
Dermatology Research AssociatesRecruiting
Los Angeles, California, United States
Northridge Clinical TrialsRecruiting
Northridge, California, United States
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Sacramento, California, United States
Golden State Dermatology - Walnut Creek - Ygnacio Valley RoadRecruiting
Walnut Creek, California, United States
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Wheat Ridge, Colorado, United States
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Clearwater, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical ResearchRecruiting
Tampa, Florida, United States
Dermatology Affiliates Research InstituteRecruiting
Atlanta, Georgia, United States
Advanced Medical Research, PC.Recruiting
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLCRecruiting
Indianapolis, Indiana, United States
Local Institution - 0262Not Yet Recruiting
Murray, Kentucky, United States
Local Institution - 0202Not Yet Recruiting
Metairie, Louisiana, United States
Dermatology and Skin Cancer Specialists, LLCRecruiting
Rockville, Maryland, United States
Kuchnir Dermatology & Dermatologic SurgeryRecruiting
Milford, Massachusetts, United States
Local Institution - 0095Not Yet Recruiting
Detroit, Michigan, United States
Local Institution - 0233Not Yet Recruiting
Columbia, Missouri, United States
Local Institution - 0266Not Yet Recruiting
Lee's Summit, Missouri, United States
JDR Dermatology ResearchRecruiting
Las Vegas, Nevada, United States
Local Institution - 0166Not Yet Recruiting
The Bronx, New York, United States
Hickory Dermatology Research CenterRecruiting
Hickory, North Carolina, United States
Apex Clinical Research Center - CantonRecruiting
Canton, Ohio, United States
Apex Clinical Research CenterRecruiting
Mayfield Heights, Ohio, United States
Paddington Testing CompanyRecruiting
Philadelphia, Pennsylvania, United States
ObjectiveHealth - Goodlettsville Dermatology ResearchRecruiting
Goodlettsville, Tennessee, United States
Belle Meade Dermatology ResearchRecruiting
Nashville, Tennessee, United States
Local Institution - 0268Not Yet Recruiting
Austin, Texas, United States
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Cedar Park, Texas, United States
Texas Dermatology and Laser SpecialistsRecruiting
San Antonio, Texas, United States
Local Institution - 0045Not Yet Recruiting
Norfolk, Virginia, United States
Frontier Derm PartnersRecruiting
Mill Creek, Washington, United States
Local Institution - 0264Not Yet Recruiting
Spokane, Washington, United States
Local Institution - 0115Not Yet Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0119Not Yet Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0149Not Yet Recruiting
Buenos Aires, Argentina
Local Institution - 0221Not Yet Recruiting
Buenos Aires, Argentina
Local Institution - 0250Not Yet Recruiting
Buenos Aires, Argentina
Local Institution - 0154Not Yet Recruiting
Buenos Aires, Argentina
Cliniques universitaires Saint-LucRecruiting
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0210Withdrawn
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ GentRecruiting
Ghent, Oost-Vlaanderen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanRecruiting
Liège, Belgium
Local Institution - 0137Not Yet Recruiting
Salvador, Estado de Bahia, Brazil
Local Institution - 0182Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Edmonton, Alberta, Canada
Local Institution - 0164Not Yet Recruiting
Winnipeg, Manitoba, Canada
Skincare StudioRecruiting
St. John's, Newfoundland and Labrador, Canada
DermEffectsRecruiting
London, Ontario, Canada
The Centre for DermatologyRecruiting
Richmond Hill, Ontario, Canada
AvantDermRecruiting
Toronto, Ontario, Canada
Local Institution - 0240Not Yet Recruiting
Toronto, Ontario, Canada
Local Institution - 0142Not Yet Recruiting
Montreal, Quebec, Canada
Beijing Children's hospital, Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
The University of Hong Kong-Shenzhen HospitalRecruiting
Shenzhen, Guangdong, China
The Affiliated Hospital of Hebei University of EngineeringRecruiting
Handan, Hebei, China
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Zhengzhou, Henan, China
Hunan Children's HospitalRecruiting
Changsha, Hunan, China
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Jinan, Shandong, China
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Shanghai, Shanghai Municipality, China
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Chengdu, Sichuan, China
The First People's Hospital of HangzhouRecruiting
Hangzhou, Zhejiang, China
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Medellín, Antioquia, Colombia
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
Local Institution - 0125Not Yet Recruiting
Bogota, Cundinamarca, Colombia
Universitätsklinikum MünsterRecruiting
Münster, North Rhine-Westphalia, Germany
BAG Drs. Med. Quist PartGRecruiting
Mainz, Rhineland-Palatinate, Germany
Charité Universitaetsmedizin Berlin - Campus MitteRecruiting
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Universitaetsklinikum ErlangenRecruiting
Erlangen, Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai KözpontRecruiting
Szeged, Csongrád megye, Hungary
Clinexpert Kft.Recruiting
Budapest, Pest County, Hungary
Debreceni Egyetem Klinikai KozpontRecruiting
Debrecen, Hungary
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
Roma, Italy
Local Institution - 0238Not Yet Recruiting
Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
Local Institution - 0259Not Yet Recruiting
Chihuahua City, Mexico
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Mérida, Mexico
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Toluca, Mexico
Local Institution - 0096Not Yet Recruiting
Veracruz, Mexico
Local Institution - 0177Withdrawn
Lublin, Lublin Voivodeship, Poland
FutureMeds - TargowekRecruiting
Warsaw, Masovian Voivodeship, Poland
SPECDERM Poznanska sp.j.Recruiting
Bialystok, Podlaskie Voivodeship, Poland
"DERMED" Centrum Medyczne Sp. z o.o.Recruiting
Lodz, Poland
ETYKA Osrodek Badan KlinicznychRecruiting
Olsztyn, Poland
Klinika Ambroziak DermatologiaRecruiting
Warsaw, Poland
Royalderm Agnieszka NawrockaRecruiting
Warsaw, Poland
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Bayamón, Puerto Rico
Local Institution - 0008Not Yet Recruiting
Caguas, Puerto Rico
Local Institution - 0012Not Yet Recruiting
San Juan, Puerto Rico
Local Institution - 0174Withdrawn
Bucharest, Bucharest, Romania
Lotus-Med TunariRecruiting
Bucharest, Bucharest, Romania
Local Institution - 0213Withdrawn
Bucharest, Bucharest, Romania
Policlinica ProvidențaRecruiting
Iași, Romania
Centrul de Medicina de FamilieRecruiting
Iași, Romania
New Derm Clinical SRLRecruiting
Timișoara, Romania
Hospital Sant Joan de DéuRecruiting
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Grupo Dermatológico y Estético Pedro Jaén S.ARecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
CHUS - Hospital Clinico UniversitarioRecruiting
Santiago de Compostela, Spain
Chang Gung Memorial Hospital at KaohsiungRecruiting
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Kaohsiung Veterans General HospitalRecruiting
Kaohsiung City, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchRecruiting
Taoyuan District, Taiwan