A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-17
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA).

Participants must have at least three joints that are affected by arthritis.

Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.

Disqualifiers

Participants must not have been diagnosed with JPsA before 5 years of age.

Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA,

Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Deucravacitinib

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to first flare during the withdrawal period

Time frame
From week 16 up to week 42

Secondary outcomes

1

Trough concentration at steady state (Cminss)

Time frame
At week 16
2

Time-averaged steady-state concentration (Cavgss)

Time frame
At week 16
3

Steady-state maximum observed concentration (Cmaxss)

Time frame
At week 16
4

Number of participants with flare during the withdrawal period

Time frame
From week 16 up to week 42

Other outcomes

Sponsors and contacts

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