Clinical trial NCT06979453: A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Rash
Itch
Teen
Dermatology
Derm
POETYK-PsO-Peds-1
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 366
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Primary outcomes:
measure: Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
timeFrame: At week 16
measure: 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
timeFrame: At week 16
Secondary outcomes:
measure: Number of participants achieving at least 90% improvement in PASI (PASI 90)
timeFrame: At week 16
measure: Change from baseline in PASI
timeFrame: At week 16
measure: Change from baseline in body surface area (BSA) involvement
timeFrame: At week 16
measure: Change from baseline in worst itch numeric rating scale (WI-NRS)
timeFrame: At week 16
measure: Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)
timeFrame: At week 16
measure: Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score
timeFrame: At week 16
measure: Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)
timeFrame: At week 16
measure: Number of participants with treatment emergent adverse events
timeFrame: Up to 5 years
measure: Number of participants with serious adverse events
timeFrame: Up to 5 years
measure: Number of participants with clinically significant changes in laboratory parameters
timeFrame: Up to 5 years
measure: Number of participants with clinically significant changes in physical examinations
timeFrame: Up to 5 years
measure: Number of participants with clinically significant changes in vital signs
timeFrame: Up to 5 years
measure: Number of participants with protective titers of antibodies to measles
timeFrame: At week 16
measure: Number of participants with protective titers of antibodies to tetanus
timeFrame: At week 16
measure: Number of participants with protective titers of antibodies to pertussis
timeFrame: At week 16
measure: Body weight
timeFrame: Up to 5 years
measure: Height
timeFrame: Up to 5 years
measure: Sexual maturation
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Local Institution - 0025
state: California
city: Fremont
country: United States
facility: Local Institution - 0090
state: California
city: Northridge
country: United States
facility: Local Institution - 0214
state: California
city: Sacramento
country: United States
facility: Local Institution - 0077
state: California
city: Walnut Creek
country: United States
facility: Local Institution - 0243
state: California
city: Wheat Ridge
country: United States
facility: Local Institution - 0231
state: Colorado
city: Clearwater
country: United States
facility: Local Institution - 0021
state: Florida
city: Margate
country: United States
facility: Local Institution - 0185
state: Florida
city: Miami Lakes
country: United States
facility: Local Institution - 0014
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0070
state: Florida
city: Metairie
country: United States
facility: Local Institution - 0202
state: Louisiana
city: Marlborough
country: United States
facility: Local Institution - 0220
state: Massachusetts
city: Dearborn
country: United States
facility: Local Institution - 0095
state: Michigan
city: Columbia
country: United States
facility: Local Institution - 0233
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution - 0052
state: Nevada
city: Hickory
country: United States
facility: Local Institution - 0234
state: North Carolina
city: Goodlettsville
country: United States
facility: Local Institution - 0235
state: Tennessee
city: San Antonio
country: United States
facility: Local Institution - 0033
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 0045
state: Virginia
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0115
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0119
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0149
city: Buenos Aires
country: Argentina
facility: Local Institution - 0221
city: Buenos Aires
country: Argentina
facility: Local Institution - 0250
city: Buenos Aires
country: Argentina
facility: Local Institution - 0154
city: Brussels
country: Belgium
facility: Local Institution - 0209
state: Bruxelles-Capitale, Région De
city: Brussels
country: Belgium
facility: Local Institution - 0210
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: Local Institution - 0207
state: Oost-Vlaanderen
city: Salvador
country: Brazil
facility: Local Institution - 0137
state: Bahia
city: Porto Alegre
country: Brazil
facility: Local Institution - 0136
state: Rio Grande Do Sul
city: Calgary
country: Canada
facility: Local Institution - 0107
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 0241
state: Alberta
city: Winnipeg
country: Canada
facility: Local Institution - 0164
state: Manitoba
city: St. John's
country: Canada
facility: Local Institution - 0242
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Local Institution - 0240
state: Ontario
city: Montréal
country: Canada
facility: Local Institution - 0142
state: Quebec
city: Beijing
country: China
facility: Local Institution - 0222
state: Beijing
city: Shenzhen
country: China
facility: Local Institution - 0226
state: Guangdong
city: Zhengzhou
country: China
facility: Local Institution - 0227
state: Henan
city: Hangzhou
country: China
facility: Local Institution - 0224
state: Zhejiang
city: Medellín
country: Colombia
facility: Local Institution - 0225
state: Antioquia
city: Medellín
country: Colombia
facility: Local Institution - 0124
state: Antioquia
city: Barranquilla
country: Colombia
facility: Local Institution - 0167
state: Atlántico
city: Bogota
country: Colombia
facility: Local Institution - 0125
state: Cundinamarca
city: Münster
country: Germany
facility: Local Institution - 0195
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Local Institution - 0194
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Local Institution - 0211
city: Dresden
country: Germany
facility: Local Institution - 0204
city: Erlangen
country: Germany
facility: Local Institution - 0193
city: Budapest
country: Hungary
facility: Local Institution - 0153
city: Mexico City
country: Mexico
facility: Local Institution - 0253
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution - 0238
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0155
state: Nuevo León
city: Puebla
country: Mexico
facility: Local Institution - 0237
city: Veracruz
country: Mexico
facility: Local Institution - 0096
city: Warsaw
country: Poland
facility: Local Institution - 0212
state: Mazowieckie
city: Bialystok
country: Poland
facility: Local Institution - 0103
state: Podlaskie
city: Caguas
country: Puerto Rico
facility: Local Institution - 0008
city: Bucharest
country: Romania
facility: Local Institution - 0249
state: București
city: Bucuresti
country: Romania
facility: Local Institution - 0174
state: București
city: Bucuresti
country: Romania
facility: Local Institution - 0213
state: București
city: Timișoara
country: Romania
facility: Local Institution - 0200
state: Timiș
city: Esplugues de Llobregat
country: Spain
facility: Local Institution - 0218
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Local Institution - 0216
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0197
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: