A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent 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

Overview

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent 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 children and adolescent 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 children and adolescent participants with psoriasis who have completed Parts A or B of the study.

Interventions

• Drug Deucravacitinib
  Specified dose on specified days
• Other Placebo matching deucravacitinib
  Specified dose on specified days

Primary outcome measures

• Observed average concentration at steady state for deucravacitinib at Week 2 [Time frame: Week 2]
• Maximum observed plasma concentration at steady state for deucravacitinib at Week 2 [Time frame: Week 2]
• Trough observed plasma concentration for deucravacitinib at Week 2 [Time frame: Week 2]
• Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 [Time frame: Week 16]
• 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 [Time frame: Week 16]
• Incidence of Adverse Events (AEs) [Time frame: Up to 316 weeks]
• Incidence of serious adverse events (SAEs) [Time frame: Up to 316 weeks]
• Monitoring of growth: Body weight [Time frame: Up to 316 weeks]
• Monitoring of growth: Height [Time frame: Up to 316 weeks]
• Monitoring of growth: Tanner staging (sexual maturation) [Time frame: Up to 316 weeks]

Secondary outcome measures (12)

• Incidence of Adverse Events (AEs) [Time frame: Up to Week 52]
• Incidence of serious adverse events (SAEs) [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests [Time frame: Up to Week 52]
• Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only [Time frame: Up to Week 52]
• Incidence of clinically significant changes in lymphocyte subsets and function [Time frame: Up to Week 52]
• Incidence of clinically significant changes in cytokine levels [Time frame: Up to Week 52]

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 another active comparator.
• Evidence of active TB for LTE period.
• Other protocol-defined inclusion/exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Japan · 7 centers

• Nagoya City University Hospital — Nagoya
• Fukuoka University Hospital — Fukuoka, Jonan-Ku
• Local Institution - 0040 — Isehara
• Mie University Hospital — Tsu
• Teikyo University Hospital — Itabashi-ku
• Tokyo Medical University Hospital — Shinjuku-ku
• Nippon Life Hospital — Osaka

Romania · 7 centers

• Local Institution - 0080 — Bucharest
• Local Institution - 0081 — Bucharest
• Local Institution - 0088 — Bucharest
• CCBR Clinical Research — Bucharest
• Lotus-Med Tunari — Bucharest
• Spitalul clinic de urgenta pentru copii Sf. Maria — Iași
• Spitalul Clinic Judetean Mures — Târgu Mureş

Argentina · 6 centers

• Instituto de Neumonologia Y Dermatologia — Ciudad Autonoma de Buenos Aires
• Psoriahue — Ciudad Autonoma de Buenos Aires
• CONEXA Investigacion Clinica S.A. — Buenos Aires
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
• Hospital Italiano de Buenos Aires — CABA
• Consultora Integral de Salud — Córdoba

Australia · 6 centers

• The Skin Hospital — Darlinghurst
• Local Institution - 0002 — Westmead
• Queensland Children's Hospital — Brisbane
• Veracity Clinical Research — Woolloongabba
• Monash Health — Clayton
• Local Institution - 0001 — Melbourne

Spain · 6 centers

• Hospital General Universitario de Alicante-Dermatology — Alicante
• OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology — Barakaldo
• Hospital Sant Joan de Déu-URC Dermatology — Esplugues de Llobregat
• Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología — Las Palmas de GC
• Hospital Universitario 12 de Octubre-DERMATOLOGY — Madrid
• Hospital Universitario La Paz-UCICEC/DERMA — Madrid

Brazil · 5 centers

• Centro de Pesquisas da Clínica IBIS — Salvador
• Hospital Moinhos de Vento — Porto Alegre
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Pa — Ribeirão Preto
• Local Institution - 0083 — Rio de Janeiro
• Local Institution - 0067 — São Paulo

Canada · 5 centers

• Local Institution - 0010 — Calgary
• Alberta Dermasurgery Centre — Edmonton
• Local Institution - 0039 — Hamilton
• Lynderm Research Inc. — Markham
• The Hospital for Sick Children — Toronto

Germany · 5 centers

• Universitätsklinikum Münster — Münster
• Universitätsmedizin Johannes Gutenberg Universität Mainz — Mainz
• Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
• Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin
• Kath. Kinderkrankenhaus Wilhelmstift — Hamburg

France · 4 centers

• Centre Hospitalier de Calais — Calais
• Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology — Dijon
• Centre Hospitalier Universitaire de Nice - Hôpital l'Archet — Nice
• Local Institution - 0021 — Paris

Mexico · 4 centers

• Crea de Guadalajara — Guadalajara
• Grupo Clínico CATEI S.C. — Guadalajara
• RM Pharma Specialists — Mexico City
• Arké SMO S.A de C.V — Veracruz

Poland · 4 centers

• Local Institution - 0011 — Krakow
• Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak — Lodz
• Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii — Warsaw
• WroMedica — Wroclaw

South Korea · 3 centers

• Local Institution - 0048 — Seoul
• Local Institution - 0047 — Seoul
• The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul

United Kingdom · 1 center

• Mounts Bay Medical — Connor Downs

Identifiers

NCT: NCT04772079 · IM011-126 · 2022-502519-13

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗