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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis

Treatments: Other: Placebo matching deucravacitinib; Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04772079

2019-004879-39 (EudraCT Number)

IM011-126

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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153 participants in 3 patient groups, including a placebo group

Active treatment deucravacitinib standard dose

Experimental group

Treatment:

Drug: Deucravacitinib

Active treatment deucravacitinib half-standard dose

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo

Placebo Comparator group

Treatment:

Other: Placebo matching deucravacitinib