A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Other: Placebo matching deucravacitinib
- Registration Number
- NCT04772079
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 153
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Active treatment deucravacitinib half-standard dose Deucravacitinib - Placebo Placebo matching deucravacitinib - Active treatment deucravacitinib standard dose Deucravacitinib -
- Primary Outcome Measures
Name Time Method 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 Week 16 Part B
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2 Week 2 Part A
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2 Week 2 Part A
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2 Week 2 Part A
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 Week 16 Part B
Incidence of Adverse Events (AEs) Up to 316 weeks Long-term extension (LTE) Period
Incidence of serious adverse events (SAEs) Up to 316 weeks LTE Period
Monitoring of growth: Body weight Up to 316 weeks LTE Period
Monitoring of growth: Height Up to 316 weeks LTE Period
Monitoring of growth: Tanner staging (sexual maturation) Up to 316 weeks LTE Period
- Secondary Outcome Measures
Name Time Method Monitoring of growth: Body weight Up to 466 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests Up to 368 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests Up to 368 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only Up to 466 days Part A and Part B
Incidence of clinically significant changes in vital signs: Respiratory rate Up to 466 days Part A and Part B
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure Up to 466 days Part A and Part B
Incidence of clinically significant changes in vital signs: Heart rate Up to 466 days Part A and Part B
Incidence of Adverse Events (AEs) Up to 424 days Part A and Part B
Incidence of serious adverse events (SAEs) Up to 466 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 466 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests Up to 466 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 466 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests Up to 410 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests Up to 42 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests Up to 42 days Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests Up to 368 days Part A and Part B
Incidence of clinically significant changes in vital signs: Body temperature Up to 466 days Part A and Part B
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 Week 16 Part B
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo Week 16 Part B
Incidence of clinically significant changes in lymphocyte subsets and function Up to 466 days Part A and Part B
Incidence of clinically significant changes in cytokine levels Up to 466 days Part A and Part B
Incidence of clinically significant changes in physical examination findings Up to 466 days Part A and Part B
Monitoring of growth: Tanner staging (sexual maturation) Up to 466 days Part A and Part B
Monitoring of growth: Height Up to 466 days Part A and Part B
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 Week 16 Part B
Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo Week 16 Part B
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo Week 16 Part B
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo Week 16 Part B
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 Week 16 Part B
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 Week 16 Part B
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 Week 16 Part B
ACR Pedi 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by \> 30% for comparison of deucravacitinib vs placeboProportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo Week 16 Part B
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 Week 16 Part B
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16 Week 16 Part B
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 Up to 316 weeks LTE Period
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16 Week 16 Part B
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16 Week 16 Part B
Proportion of participants with 75% improvement in PASI (PASI 75) over time Up to 316 weeks LTE Period
Trial Locations
- Locations (63)
Local Institution - 0011
🇵🇱Krakow, Poland
Centro de Pesquisas da Clínica IBIS
🇧🇷Salvador, Bahia, Brazil
Instituto de Neumonologia Y Dermatologia
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Psoriahue
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CONEXA Investigacion Clinica S.A.
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Caba, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Local Institution - 0089
🇦🇷Córdoba, Argentina
The Skin Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Local Institution - 0002
🇦🇺Westmead, New South Wales, Australia
Queensland Children's Hospital
🇦🇺Brisbane, Queensland, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Local Institution - 0001
🇦🇺Melbourne, Victoria, Australia
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0064
🇧🇷Ribeirão Preto, São Paulo, Brazil
Local Institution - 0083
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0067
🇧🇷São Paulo, Brazil
Local Institution - 0010
🇨🇦Calgary, Alberta, Canada
Alberta Dermasurgery Centre
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0039
🇨🇦Hamilton, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Local Institution - 0090
🇫🇷Calais, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
🇫🇷Dijon, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
🇫🇷Nice, France
Local Institution - 0021
🇫🇷Paris, France
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Sachsen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
🇩🇪Berlin, Germany
Kath. Kinderkrankenhaus Wilhelmstift
🇩🇪Hamburg, Germany
Local Institution - 0033
🇯🇵Nagoya, Aichi, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Jonan-Ku, Fukuoka, Japan
Local Institution - 0040
🇯🇵Isehara, Kanagawa, Japan
Local Institution - 0038
🇯🇵Tsu, Mie, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Local Institution - 0041
🇯🇵Shinjuku-ku, Tokyo, Japan
Nippon Life Hospital
🇯🇵Osaka, Japan
Local Institution - 0048
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0047
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Crea de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Grupo Clínico CATEI S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
🇵🇱Warsaw, Poland
WroMedica
🇵🇱Wroclaw, Poland
Local Institution - 0080
🇷🇴Bucharest, București, Romania
Lotus-Med Tunari
🇷🇴Bucharest, București, Romania
Local Institution - 0088
🇷🇴Bucharest, București, Romania
Local Institution - 0081
🇷🇴Bucuresti, București, Romania
CCBR Clinical Research
🇷🇴Bucuresti, București, Romania
Spitalul clinic de urgenta pentru copii Sf. Maria
🇷🇴Iasi, Romania
Spitalul Clinic Judetean Mures
🇷🇴Targu Mures, Romania
Hospital General Universitario de Alicante-Dermatology
🇪🇸Alicante, Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology
🇪🇸Barakaldo, Spain
Hospital Sant Joan de Déu-URC Dermatology
🇪🇸Esplugues de Llobregat, Spain
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
🇪🇸Las Palmas De GC, Spain
Hospital Universitario 12 de Octubre-DERMATOLOGY
🇪🇸Madrid, Spain
Hospital Universitario La Paz-UCICEC/DERMA
🇪🇸Madrid, Spain
Mounts Bay Medical
🇬🇧Connor Downs, United Kingdom