Health TrialsbyHealthPanel

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

ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-18
SponsorBristol-Myers Squibb

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Deucravacitinib

    Drug

    Specified dose on specified days

  • Placebo matching deucravacitinib

    Other intervention

    Specified dose on specified days

Treatment groups

153 Participants
are divided into 3 treatment groups
Group A: Active treatment deucravacitinib standard doseExperimental treatment 1 intervention
Group B: Active treatment deucravacitinib half-standard doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Observed average concentration at steady state for deucravacitinib at Week 2

Part A

Time frame
Week 2
2

Maximum observed plasma concentration at steady state for deucravacitinib at Week 2

Part A

Time frame
Week 2
3

Trough observed plasma concentration for deucravacitinib at Week 2

Part A

Time frame
Week 2
4

Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16

Part B

Time frame
Week 16

Secondary outcomes

1

Incidence of Adverse Events (AEs)

Part A and Part B

Time frame
Up to Week 52
2

Incidence of serious adverse events (SAEs)

Part A and Part B

Time frame
Up to Week 52
3

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Part A and Part B

Time frame
Up to Week 52
4

Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests

Part A and Part B

Time frame
Up to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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