A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06979453
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
366 participants
INTERVENTIONAL
2025-11-15
2034-08-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Administration of Deucravacitinib
Deucravacitinib
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0041
Birmingham, Alabama, United States
Local Institution - 0025
Fountain Valley, California, United States
Local Institution - 0090
Fremont, California, United States
Local Institution - 0214
Northridge, California, United States
Local Institution - 0077
Sacramento, California, United States
Local Institution - 0243
Walnut Creek, California, United States
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado, United States
Local Institution - 0021
Clearwater, Florida, United States
Local Institution - 0185
Margate, Florida, United States
Skin Research of South Florida
Miami, Florida, United States
Local Institution - 0014
Miami Lakes, Florida, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
Dermatology Affiliates Research Institute
Atlanta, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Local Institution - 0202
Metairie, Louisiana, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, United States
Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts, United States
Local Institution - 0095
Detroit, Michigan, United States
Local Institution - 0233
Columbia, Missouri, United States
Local Institution - 0052
Las Vegas, Nevada, United States
Local Institution - 0166
The Bronx, New York, United States
Local Institution - 0234
Hickory, North Carolina, United States
Apex Clinical Research Center - Canton
Canton, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Local Institution - 0248
Nashville, Tennessee, United States
Local Institution - 0033
San Antonio, Texas, United States
Local Institution - 0045
Norfolk, Virginia, United States
Local Institution - 0071
Mill Creek, Washington, United States
Local Institution - 0115
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0119
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0149
Buenos Aires, , Argentina
Local Institution - 0221
Buenos Aires, , Argentina
Local Institution - 0250
Buenos Aires, , Argentina
Local Institution - 0154
Buenos Aires, , Argentina
Local Institution - 0209
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0210
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0207
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0137
Salvador, Estado de Bahia, Brazil
Local Institution - 0182
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0136
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0140
Barretos, São Paulo, Brazil
Local Institution - 0163
Ribeirão Preto, São Paulo, Brazil
Local Institution - 0241
Edmonton, Alberta, Canada
Local Institution - 0164
Winnipeg, Manitoba, Canada
Local Institution - 0242
St. John's, Newfoundland and Labrador, Canada
DermEffects
London, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
AvantDerm
Toronto, Ontario, Canada
Local Institution - 0240
Toronto, Ontario, Canada
Local Institution - 0142
Montreal, Quebec, Canada
Local Institution - 0222
Beijing, Beijing Municipality, China
Local Institution - 0226
Shenzhen, Guangdong, China
Local Institution - 0255
Handan, Hebei, China
Local Institution - 0227
Zhengzhou, Henan, China
Local Institution - 0228
Chengdu, Sichuan, China
Local Institution - 0224
Hangzhou, Zhejiang, China
Local Institution - 0225
Medellín, Antioquia, Colombia
Local Institution - 0124
Medellín, Antioquia, Colombia
Local Institution - 0167
Barranquilla, Atlántico, Colombia
Local Institution - 0125
Bogota, Cundinamarca, Colombia
Local Institution - 0195
Münster, North Rhine-Westphalia, Germany
Local Institution - 0194
Mainz, Rhineland-Palatinate, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, , Germany
Local Institution - 0204
Dresden, , Germany
Local Institution - 0193
Erlangen, , Germany
Local Institution - 0153
Budapest, , Hungary
Local Institution - 0238
Zapopan, Jalisco, Mexico
Local Institution - 0253
Mexico City, Mexico City, Mexico
Local Institution - 0155
Monterrey, Nuevo León, Mexico
Local Institution - 0259
Chihuahua City, , Mexico
Local Institution - 0257
Mérida, , Mexico
Local Institution - 0237
Puebla City, , Mexico
Local Institution - 0258
Toluca, , Mexico
Local Institution - 0096
Veracruz, , Mexico
Local Institution - 0177
Lublin, Lublin Voivodeship, Poland
Local Institution - 0178
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0212
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0103
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0101
Olsztyn, , Poland
Local Institution - 0008
Caguas, , Puerto Rico
Local Institution - 0012
San Juan, , Puerto Rico
Local Institution - 0174
Bucharest, București, Romania
Local Institution - 0249
Bucharest, București, Romania
Local Institution - 0213
Bucharest, București, Romania
Local Institution - 0181
Iași, , Romania
Local Institution - 0173
Iași, , Romania
Local Institution - 0200
Timișoara, , Romania
Local Institution - 0218
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Local Institution - 0197
Santiago de Compostela, , Spain
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0041
Role: primary
Site 0025
Role: primary
Site 0090
Role: primary
Site 0214
Role: primary
Site 0077
Role: primary
Site 0243
Role: primary
Kimberly Neyman, Site 0231
Role: primary
Site 0021
Role: primary
Site 0185
Role: primary
Giovanna Ciocca, Site 0043
Role: primary
Site 0014
Role: primary
Stephen Lockwood, Site 0070
Role: primary
Anita Shetty, Site 0244
Role: primary
Scott Fretzin, Site 0003
Role: primary
Site 0202
Role: primary
Benjamin Lockshin, Site 0061
Role: primary
Shiu-Chung Au, Site 0220
Role: primary
Site 0095
Role: primary
Site 0233
Role: primary
Site 0052
Role: primary
Site 0166
Role: primary
Site 0234
Role: primary
Jorge Garcia-Zuazaga, Site 0251
Role: primary
Jorge Garcia-Zuazaga, Site 0055
Role: primary
Keith Loven, Site 0235
Role: primary
Site 0248
Role: primary
Site 0033
Role: primary
Site 0045
Role: primary
Site 0071
Role: primary
Site 0115
Role: primary
Site 0119
Role: primary
Site 0149
Role: primary
Site 0221
Role: primary
Site 0250
Role: primary
Site 0154
Role: primary
Site 0209
Role: primary
Site 0207
Role: primary
Site 0137
Role: primary
Site 0182
Role: primary
Site 0136
Role: primary
Site 0140
Role: primary
Site 0163
Role: primary
Site 0241
Role: primary
Site 0164
Role: primary
Site 0242
Role: primary
Wei Jing Loo, Site 0143
Role: primary
Mani Raman, Site 0144
Role: primary
Davindra Singh, Site 0156
Role: primary
Site 0240
Role: primary
Site 0142
Role: primary
Site 0222
Role: primary
Site 0226
Role: primary
Site 0255
Role: primary
Site 0227
Role: primary
Site 0228
Role: primary
Site 0224
Role: primary
Site 0225
Role: primary
Site 0124
Role: primary
Site 0167
Role: primary
Site 0125
Role: primary
Site 0195
Role: primary
Site 0194
Role: primary
Sonja Molin, Site 0211
Role: primary
Site 0204
Role: primary
Site 0193
Role: primary
Site 0153
Role: primary
Site 0238
Role: primary
Site 0253
Role: primary
Site 0155
Role: primary
Site 0259
Role: primary
Site 0257
Role: primary
Site 0237
Role: primary
Site 0258
Role: primary
Site 0096
Role: primary
Site 0177
Role: primary
Site 0178
Role: primary
Site 0212
Role: primary
Site 0103
Role: primary
Site 0101
Role: primary
Site 0008
Role: primary
Site 0012
Role: primary
Site 0249
Role: primary
Site 0181
Role: primary
Site 0173
Role: primary
Site 0200
Role: primary
Site 0218
Role: primary
Raquel Rivera-Diaz, Site 0216
Role: primary
Site 0197
Role: primary
Ji-Chen Ho, Site 0114
Role: primary
Chien-Hui Hong, Site 0201
Role: primary
Tsen-Fang Tsai, Site 0113
Role: primary
Yu-Huei Huang, Site 0112
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-506296-97
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1289-8030
Identifier Type: OTHER
Identifier Source: secondary_id
IM011-1128
Identifier Type: -
Identifier Source: org_study_id