RecruitingPHASE3INTERVENTIONAL

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

This research study is for children and teenagers aged 5 to 17 who have Juvenile Psoriatic Arthritis (JPsA). JPsA is a condition where young people experience joint pain and swelling, sometimes with a skin rash. The study is looking at a new medicine called Deucravacitinib. We want to find out if this medicine can help improve their symptoms and reduce the impact of JPsA on their daily lives. Researchers will also carefully check if the medicine is safe and well-tolerated. Participants will receive either the new medicine or a placebo (a dummy medicine with no active ingredients). This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

Start

13 Mar 2025

Estimated completion

04 Mar 2031

Juvenile Psoriatic Arthritis

What is this study about?

This study is investigating a new medicine called Deucravacitinib for young people aged 5 to 17 who have Juvenile Psoriatic Arthritis, often shortened to JPsA. JPsA is a long-term condition where children and teenagers experience joint pain, swelling, and stiffness, similar to what adults with psoriatic arthritis feel. They might also have skin problems like psoriasis.

The main aim of this study is to see how well Deucravacitinib works in improving the symptoms of JPsA. This includes looking at how it affects their joints and overall well-being. We also need to understand how much of the medicine is in the body of young people and, very importantly, if it is safe to use and doesn't cause too many side effects. Some participants will receive the new medicine, while others will receive a placebo, which looks like the medicine but contains no active ingredients. This helps us accurately compare the real effects of the new medicine.

Finding new and effective treatments for JPsA is important because the condition can significantly affect a young person's growth, development, and daily activities. This research could help us learn more about managing JPsA and potentially offer a new treatment option for young people living with this condition.

Key takeaways

This study is testing a new medicine for Juvenile Psoriatic Arthritis (JPsA) in children and teenagers (5-17 years old).
It aims to see how well the medicine works, how much is needed, and if it's safe.
Participants will receive either the new medicine or a placebo, and will have regular check-ups.
This is a 'Phase 3' study, meaning it's a key step in developing new treatments.
Joining is voluntary, and you can withdraw at any time.
Detailed information about risks and benefits will be provided by the study team.

Who may be eligible?

To join this study, children and teenagers generally need to be between 5 and 17 years old and have a diagnosis of Juvenile Psoriatic Arthritis (JPsA). They also need to have at least three joints that are currently affected by their arthritis.

Additionally, they should have already tried at least one other medicine for their JPsA for at least three months, but it either didn't work well enough to control their symptoms or caused unpleasant side effects.

There are also some reasons why someone might not be able to join. For example, if they were diagnosed with JPsA before they were 5 years old, or if they have other types of juvenile arthritis that are not JPsA. Also, if they have certain eye conditions (like chronic eye inflammation or if they've had it in the last three months), they might not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 5 and 17 years old?
Does your child have a diagnosis of Juvenile Psoriatic Arthritis (JPsA)?
Does your child currently have at least three joints affected by arthritis?
Has your child tried at least one other JPsA medicine for 3 months or more, which didn't work well or caused problems?
Was your child diagnosed with JPsA at 5 years of age or older?
Does your child NOT have other types of juvenile arthritis that are not JPsA?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your child will be given either the new medicine, Deucravacitinib, or a placebo (a dummy medicine). You won't know which one they are getting. Throughout the study, your child will have regular visits to the clinic. At these visits, doctors and nurses will check their health, do physical exams, and may take blood and urine samples. This helps them understand how the medicine is working and if it's safe. You'll be asked about your child's symptoms and how they are feeling. The study will last for a certain period, and you'll receive detailed information about the exact schedule of visits and what each visit involves before you make a decision.

Potential risks and benefits

Taking part in this study could potentially offer some benefits if the new medicine helps to improve your child's JPsA symptoms. However, as with any medicine, there are also potential risks, and Deucravacitinib could cause side effects. These will be fully explained by the study team. Some participants will receive a placebo and might not experience any direct benefits from the study medicine. You are completely free to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (47)

Local Institution - 0038
Verified postcode
Lancaster, United States· Withdrawn
Local Institution - 0020
Verified postcode
Chicago, United States· Withdrawn
Local Institution - 0023
Verified postcode
Indianapolis, United States· Withdrawn
Local Institution - 0059
Verified postcode
North New Hyde Park, United States· Withdrawn
Local Institution - 0065
Verified postcode
Cincinnati, United States· Withdrawn
Local Institution - 0066
Verified postcode
Cleveland, United States· Withdrawn
Local Institution - 0036
Verified postcode
Austin, United States· Withdrawn
Local Institution - 0068
Verified postcode
Fortaleza, Brazil· Not yet recruiting
Local Institution - 0032
Verified postcode
Cuiabá, Brazil· Withdrawn
Santa Casa de Misericordia de Belo Horizonte
Verified postcode
Belo Horizonte, Brazil· Recruiting
Local Institution - 0013
Verified postcode
Curitiba, Brazil· Withdrawn
Local Institution - 0072
Verified postcode
Curitiba, Brazil· Not yet recruiting

Common questions

What is Juvenile Psoriatic Arthritis (JPsA)?

JPsA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness. It can sometimes be linked to a skin condition called psoriasis.

What is Deucravacitinib?

Deucravacitinib is a new medicine being studied to see if it can help treat JPsA.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine.

Will my child definitely feel better on this medicine?

We don't know for sure. This study is designed to find out if the medicine works and is safe. Some children will get the new medicine, and others will get a placebo.

How long will my child need to be in the study?

The study team will give you all the details about the exact length of the study and how many visits will be needed.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.