Skip to content

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

Plaque Psoriasis

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.

null

Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    4 to 18

Participation 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

Study Location

Dermatology Research Institute
Dermatology Research Institute
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Vimal Prajapati, Site 0010

403-263-3376
The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Rebecca Levy, Site 0050

4168137654x428232
Lynderm Research Inc.
Lynderm Research Inc.
Markham, Ontario
Canada

Contact Study Team

Primary Contact

Charles Lynde, Site 0008

9054718011
Alberta Dermasurgery Centre
Alberta Dermasurgery Centre
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Jaggi Rao, Site 0037

7809060540
Local Institution - 0039
Local Institution - 0039
Hamilton, Ontario
Canada

Contact Study Team

Local Institution - 0010
Local Institution - 0010
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
Bristol-Myers Squibb
Participants Required
More Information
Study ID: NCT04772079