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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Juvenile Psoriatic Arthritis

Treatments: Other: Placebo; Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06869551

IM011-1071

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Treatment:

Drug: Deucravacitinib

Arm B

Placebo Comparator group

Treatment:

Drug: Deucravacitinib

Other: Placebo