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A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis

NCT04772079

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Plaque Psoriasis

Interventions: Deucravacitinib, Placebo matching deucravacitinib

Countries: Argentina, Australia, Brazil, Canada, France, Germany, Japan, Mexico

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.

Eligibility overview

Sex: ALL

Age: 4 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (65)
  • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
  • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Córdoba, Argentina
  • Darlinghurst, New South Wales, Australia
  • Westmead, New South Wales, Australia
  • Brisbane, Queensland, Australia
  • Woolloongabba, Queensland, Australia
  • Clayton, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Salvador, Estado de Bahia, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Ribeirão Preto, São Paulo, Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Hamilton, Ontario, Canada
  • Markham, Ontario, Canada
  • Toronto, Ontario, Canada
  • Calais, France
  • Dijon, France
  • Nice, France
  • Paris, France
  • Münster, North Rhine-Westphalia, Germany
  • Mainz, Rhineland-Palatinate, Germany
  • Dresden, Saxony, Germany
  • Berlin, Germany
  • + 35 more on CT.gov