A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Launched by BRISTOL-MYERS SQUIBB · Feb 24, 2021
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called Deucravacitinib to see how well it works and how safe it is for children and teenagers aged 4 to under 18 years who have moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. The study is divided into two groups based on age: one group for kids aged 12 to under 18 and another for those aged 4 to under 12. Participants will first have their drug levels measured, and then they will receive one of two dose levels of the medication to determine how effective it is and if there are any side effects. Additionally, there is a long-term follow-up period to monitor the safety of the drug over time.
To be eligible for this study, kids must have had plaque psoriasis for at least six months and have moderate to severe symptoms. They should also be candidates for other treatments like light therapy or systemic therapy (medications that affect the whole body). However, children weighing less than 30 kg for the older group or less than 18 kg for the younger group cannot participate, and those with other types of psoriasis or certain health issues may also be excluded. Participants can expect to be closely monitored during the trial, and their involvement could provide valuable information on treating psoriasis in children.
Gender
ALL
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
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Toronto, Ontario, Canada
Madrid, , Spain
Dijon, , France
Westmead, New South Wales, Australia
Itabashi Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Tsu, Mie, Japan
Hamburg, , Germany
Krakow, , Poland
Nagoya, Aichi, Japan
Alicante, , Spain
Warszawa, , Poland
Brisbane, Queensland, Australia
East Melbourne, Victoria, Australia
Clayton, Victoria, Australia
Woolloongabba, Queensland, Australia
Münster, Nordrhein Westfalen, Germany
Caba, , Argentina
Esplugues De Llobregat, , Spain
Lodz, , Poland
Caba, , Argentina
Osaka, , Japan
Edmonton, Alberta, Canada
Fukuoka, Jonan Ku, Fukuoka, Japan
Bucuresti, , Romania
Lodz, , Poland
Darlinghurst, New South Wales, Australia
Markham, Ontario, Canada
Mainz, Rheinland Pfalz, Germany
Calgary, Alberta, Canada
Iasi, , Romania
Nice, , France
Connor Downs, , United Kingdom
Sydney, New South Wales, Australia
Woolloongabba, Queensland, Australia
Calgary, Alberta, Canada
Markham, Ontario, Canada
Montréal, Quebec, Canada
Wroclaw, , Poland
Barakaldo, , Spain
Las Palmas De Gc, , Spain
Connor Downs, , United Kingdom
Veracruz, , Mexico
Berlin, , Germany
Alicante, , Spain
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Dresden, Sachsen, Germany
Mexico City, Distrito Federal, Mexico
Westmead, New South Wales, Australia
Salvador, Bahia, Brazil
Buenos Aires, , Argentina
Madrid, , Spain
Lodz, , Poland
London, London, City Of, United Kingdom
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Dijon, , France
Nice, , France
Fukuoka, Jonan Ku, Fukuoka, Japan
Isehara, Kanagawa, Japan
Shinjuku Ku, Tokyo, Japan
Osaka, , Japan
Paris, , France
Tsu, Mie, Japan
Madrid, , Spain
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, , Argentina
Melbourne, Victoria, Australia
Toronto, Ontario, Canada
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Dijon, , France
Nice, , France
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Krakow, , Poland
Buenos Aires, , Argentina
Calgary, Alberta, Canada
Nagoya, Aichi, Japan
Itabashi Ku, Tokyo, Japan
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Mexico City, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Veracruz, , Mexico
Las Palmas De Gc, , Spain
Guadalajara, Jalisco, Mexico
Seoul, , Korea, Republic Of
Guadalajara, Jalisco, Mexico
Bucuresti, București, Romania
Warsaw, , Poland
Guadalajara, Jalisco, Mexico
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ribeirão Preto, São Paulo, Brazil
São Paulo, , Brazil
Münster, Nordrhein Westfalen, Germany
Mainz, Rheinland Pfalz, Germany
Dresden, Sachsen, Germany
Berlin, , Germany
Hamburg, , Germany
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Bucharest, București, Romania
Bucuresti, București, Romania
Bucuresti, București, Romania
Iasi, Iași, Romania
Târgu Mureș, Mureș, Romania
Brisbane, Queensland, Australia
Alicante, , Spain
Barakaldo, , Spain
Esplugues De Llobregat, , Spain
Madrid, , Spain
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, , Argentina
Wroclaw, , Poland
Warsaw, , Poland
Barakaldo, , Spain
Esplugues De Llobregat, , Spain
Madrid, , Spain
Targu Mures, , Romania
Ciudad Autónoma De Buenos Aires, , Argentina
Iasi, , Romania
Targu Mures, , Romania
Las Palmas De Gc, , Spain
Rio De Janeiro, , Brazil
Bucharest, București, Romania
Guadalajara, Jalisco, Mexico
Bucharest, București, Romania
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Bucharest, București, Romania
Porto Alegre, Rio Grande Do Sul, Brazil
Bucharest, , Romania
Porto Alegre, Rio Grande Do Sul, Brazil
Bucharest, , Romania
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Córdoba, , Argentina
Calais, , France
Ribeirão Preto, , Brazil
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bucharest, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Ribeirão Preto, , Brazil
Córdoba, , Argentina
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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