A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Recruiting · NCT04772079 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
DeucravacitinibPlacebo matching deucravacitinib
What this trial is about
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.
Who can take part
Age range
4 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed.
- Hospital General Universitario de Alicante-Dermatology - Alicante, Spain
- OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology - Barakaldo, Spain
- Charité Universitaetsmedizin Berlin - Campus Mitte - Berlin, Germany
- Lotus-Med Tunari - Bucharest, Romania
- CONEXA Investigacion Clinica S.A. - Buenos Aires, Argentina
- Centro de Investigaciones Metabólicas (CINME) - Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires - CABA, Argentina
- Centre Hospitalier de Calais - Calais, France
- Mounts Bay Medical - Connor Downs, United Kingdom
- Consultora Integral de Salud - Córdoba, Argentina
- Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology - Dijon, France
- Hospital Sant Joan de Déu-URC Dermatology - Esplugues de Llobregat, Spain
- Kath. Kinderkrankenhaus Wilhelmstift - Hamburg, Germany
- Spitalul clinic de urgenta pentru copii Sf. Maria - Iași, Romania
- Local Institution - 0011 - Krakow, Poland
- Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología - Las Palmas de GC, Spain
- Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak - Lodz, Poland
- Local Institution - 0092 - London, United Kingdom
- Hospital Universitario 12 de Octubre-DERMATOLOGY - Madrid, Spain
- Hospital Universitario La Paz-UCICEC/DERMA - Madrid, Spain
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet - Nice, France
- Nippon Life Hospital - Osaka, Japan
- Local Institution - 0021 - Paris, France
- Local Institution - 0083 - Rio de Janeiro, Brazil
- Local Institution - 0067 - São Paulo, Brazil
- Spitalul Clinic Judetean Mures - Târgu Mureş, Romania
- Arké SMO S.A de C.V - Veracruz, Mexico
- Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii - Warsaw, Poland
- WroMedica - Wroclaw, Poland
- Nagoya City University Hospital - Nagoya, Aichi-ken, Japan
- Local Institution - 0010 - Calgary, Alberta, Canada
- Alberta Dermasurgery Centre - Edmonton, Alberta, Canada
- Local Institution - 0080 - Bucharest, Bucharest, Romania
- Local Institution - 0081 - Bucharest, Bucharest, Romania
- Local Institution - 0088 - Bucharest, Bucharest, Romania
- CCBR Clinical Research - Bucharest, Bucharest, Romania
- Instituto de Neumonologia Y Dermatologia - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Psoriahue - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Centro de Pesquisas da Clínica IBIS - Salvador, Estado de Bahia, Brazil
- Fukuoka University Hospital - Fukuoka, Jonan-Ku, Fukuoka, Japan
- Crea de Guadalajara - Guadalajara, Jalisco, Mexico
- Grupo Clínico CATEI S.C. - Guadalajara, Jalisco, Mexico
- Local Institution - 0040 - Isehara, Kanagawa, Japan
- Local Institution - 0029 - London, London, City of, United Kingdom
- Local Institution - 0052 - Mexico City, Mexico City, Mexico
- Mie University Hospital - Tsu, Mie-ken, Japan
- Local Institution - 0020 - Darlinghurst, New South Wales, Australia
- Local Institution - 0002 - Westmead, New South Wales, Australia
- Universitätsklinikum Münster - Münster, North Rhine-Westphalia, Germany
- Local Institution - 0039 - Hamilton, Ontario, Canada
- Lynderm Research Inc. - Markham, Ontario, Canada
- The Hospital for Sick Children - Toronto, Ontario, Canada
- Queensland Children's Hospital - Brisbane, Queensland, Australia
- Local Institution - 0003 - Woolloongabba, Queensland, Australia
- Universitätsmedizin Johannes Gutenberg Universität Mainz - Mainz, Rhineland-Palatinate, Germany
- Hospital Moinhos de Vento - Porto Alegre, Rio Grande do Sul, Brazil
- Universitaetsklinikum Carl Gustav Carus Dresden - Dresden, Saxony, Germany
- Local Institution - 0048 - Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Local Institution - 0047 - Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- The Catholic Univ. of Korea Seoul St. Mary's Hospital - Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Showing 60 of 65 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →