Clinical trial NCT04772079: A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Adolescent Psoriasis
BMS-986165
Clinical trial
Deucravacitinib
Pediatric
Pediatric Psoriasis
Plaque Psoriasis
Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 153
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 12 to \<18 years for Cohort 1. Males and females aged 4 to \<12 years for Cohort 2.
* Plaque psoriasis for at least 6 months
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy
* Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period

Exclusion Criteria:

* Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing ≤ 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B.
* Other forms of psoriasis
* History of recent infection
* Prior exposure to deucravacitinib (BMS-986165) or active comparator
* Evidence of active TB for LTE period

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
timeFrame: Week 2
measure: Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
timeFrame: Week 2
measure: Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2
timeFrame: Week 2
measure: Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
timeFrame: Week 16
measure: Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
timeFrame: Week 16
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 316 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 316 weeks
measure: Monitoring of growth: Body weight
timeFrame: Up to 316 weeks
measure: Monitoring of growth: Height
timeFrame: Up to 316 weeks
measure: Monitoring of growth: Tanner staging (sexual maturation)
timeFrame: Up to 316 weeks
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 424 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests
timeFrame: Up to 410 days
measure: Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests
timeFrame: Up to 42 days
measure: Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests
timeFrame: Up to 42 days
measure: Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
timeFrame: Up to 368 days
measure: Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests
timeFrame: Up to 368 days
measure: Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests
timeFrame: Up to 368 days
measure: Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in lymphocyte subsets and function
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in cytokine levels
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure
timeFrame: Up to 466 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 466 days
measure: Monitoring of growth: Body weight
timeFrame: Up to 466 days
measure: Monitoring of growth: Height
timeFrame: Up to 466 days
measure: Monitoring of growth: Tanner staging (sexual maturation)
timeFrame: Up to 466 days
measure: Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
timeFrame: Week 16
measure: Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
timeFrame: Week 16
measure: Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline
timeFrame: Week 16
measure: Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo
timeFrame: Week 16
measure: Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16
timeFrame: Week 16
measure: Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16
timeFrame: Week 16
measure: Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16
timeFrame: Week 16
measure: Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16
timeFrame: Week 16
measure: Proportion of participants with 75% improvement in PASI (PASI 75) over time
timeFrame: Up to 316 weeks
measure: Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time
timeFrame: Up to 316 weeks
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia Y Dermatologia
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Psoriahue
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CONEXA Investigacion Clinica S.A.
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Córdoba
country: Argentina
facility: Local Institution - 0089
city: Darlinghurst
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0002
state: New South Wales
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0001
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS
state: Bahia
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Local Institution - 0064
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0083
city: São Paulo
country: Brazil
facility: Local Institution - 0067
city: Calgary
country: Canada
facility: Local Institution - 0010
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Dermasurgery Centre
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution - 0039
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Calais
country: France
facility: Local Institution - 0090
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
city: Paris
country: France
facility: Local Institution - 0021
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte
city: Hamburg
country: Germany
facility: Kath. Kinderkrankenhaus Wilhelmstift
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Fukuoka, Jonan-Ku
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Isehara
country: Japan
facility: Local Institution - 0040
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Nippon Life Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0048
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0047
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Crea de Guadalajara
state: Jalisco
city: Guadalajara
country: Mexico
facility: Grupo Clínico CATEI S.C.
state: Jalisco
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Krakow
country: Poland
facility: Local Institution - 0011
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
city: Warsaw
country: Poland
facility: Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
city: Wroclaw
country: Poland
facility: WroMedica
city: Bucharest
country: Romania
facility: Local Institution - 0080
state: București
city: Bucharest
country: Romania
facility: Lotus-Med Tunari
state: București
city: Bucharest
country: Romania
facility: Local Institution - 0088
state: București
city: Bucuresti
country: Romania
facility: Local Institution - 0081
state: București
city: Bucuresti
country: Romania
facility: CCBR Clinical Research
state: București
city: Iasi
country: Romania
facility: Spitalul clinic de urgenta pentru copii Sf. Maria
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante-Dermatology
city: Barakaldo
country: Spain
facility: OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu-URC Dermatology
city: Las Palmas De GC
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-DERMATOLOGY
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-UCICEC/DERMA
city: Connor Downs
country: United Kingdom
facility: Mounts Bay Medical
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: