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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years - 17 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06869551
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Brazil, Bulgaria, China, Czechia, Germany, Italy, Puerto Rico, Romania, Spain, Turkey, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Psoriatic Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Arm A

Placebo Comparator: Arm B

Interventions

Drug: - Deucravacitinib

Specified dose on specified days

Other: - Placebo

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution - 0038, Lancaster, California

Status

Not yet recruiting

Address

Local Institution - 0038

Lancaster, California, 93534

Site Contact

Site 0038

[email protected]

8559073286

Local Institution - 0020, Chicago, Illinois

Status

Not yet recruiting

Address

Local Institution - 0020

Chicago, Illinois, 60611

Site Contact

Site 0020

[email protected]

8559073286

Local Institution - 0023, Indianapolis, Indiana

Status

Not yet recruiting

Address

Local Institution - 0023

Indianapolis, Indiana, 46202

Site Contact

Site 0023

[email protected]

8559073286

Local Institution - 0059, N. New Hyde Park, New York

Status

Not yet recruiting

Address

Local Institution - 0059

N. New Hyde Park, New York, 11040

Site Contact

Site 0059

[email protected]

8559073286

Local Institution - 0065, Cincinnati, Ohio

Status

Not yet recruiting

Address

Local Institution - 0065

Cincinnati, Ohio, 45229

Site Contact

Site 0065

[email protected]

8559073286

Local Institution - 0066, Cleveland, Ohio

Status

Not yet recruiting

Address

Local Institution - 0066

Cleveland, Ohio, 44109

Site Contact

Site 0066

[email protected]

8559073286

Local Institution - 0036, Austin, Texas

Status

Not yet recruiting

Address

Local Institution - 0036

Austin, Texas, 78723

Site Contact

Site 0036

[email protected]

8559073286

International Sites

Local Institution - 0032, Cuiabá, Mato Grosso, Brazil

Status

Withdrawn

Address

Local Institution - 0032

Cuiabá, Mato Grosso, 78020-500

Local Institution - 0030, Belo Horizonte, Minas Gerais, Brazil

Status

Not yet recruiting

Address

Local Institution - 0030

Belo Horizonte, Minas Gerais, 30150-221

Site Contact

Site 0030

[email protected]

8559073286

Local Institution - 0007, Recife, Pernambuco, Brazil

Status

Not yet recruiting

Address

Local Institution - 0007

Recife, Pernambuco, 50670-420

Site Contact

Site 0007

[email protected]

8559073286

Local Institution - 0033, Porto Alegre, Rio Grande Do Sul, Brazil

Status

Not yet recruiting

Address

Local Institution - 0033

Porto Alegre, Rio Grande Do Sul, 90020-090

Site Contact

Site 0033

[email protected]

8559073286

Local Institution - 0008, Porto Alegre, Rio Grande Do Sul, Brazil

Status

Not yet recruiting

Address

Local Institution - 0008

Porto Alegre, Rio Grande Do Sul, 90480-000

Site Contact

Site 0008

[email protected]

8559073286

Local Institution - 0027, Rio de Janeiro, Brazil

Status

Not yet recruiting

Address

Local Institution - 0027

Rio de Janeiro, , 21941-612

Site Contact

Site 0027

[email protected]

8559073286

Local Institution - 0047, São Paulo, Brazil

Status

Not yet recruiting

Address

Local Institution - 0047

São Paulo, , 01223-001

Site Contact

Site 0047

[email protected]

8559073286

Local Institution - 0010, São Paulo, Brazil

Status

Withdrawn

Address

Local Institution - 0010

São Paulo, , 04022-001

Plovdiv, Bulgaria

Status

Recruiting

Address

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv, , 4002

Site Contact

Krastina Stefanova-Kelly, Site 0054

[email protected]

+359876324578

Local Institution - 0062, Sofia, Bulgaria

Status

Not yet recruiting

Address

Local Institution - 0062

Sofia, , 1797

Site Contact

Site 0062

[email protected]

8559073286

Local Institution - 0049, Beijing, Beijing, China

Status

Not yet recruiting

Address

Local Institution - 0049

Beijing, Beijing, 100045

Site Contact

Site 0049

[email protected]

8559073286

Local Institution - 0060, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Local Institution - 0060

Guangzhou, Guangdong, 510620

Site Contact

Site 0060

[email protected]

8559073286

Local Institution - 0052, Nanjing, Jiangsu, China

Status

Not yet recruiting

Address

Local Institution - 0052

Nanjing, Jiangsu, 210008

Site Contact

Site 0052

[email protected]

8559073286

Local Institution - 0053, Changchun, Jilin, China

Status

Not yet recruiting

Address

Local Institution - 0053

Changchun, Jilin, 130000

Site Contact

Site 0053

[email protected]

8559073286

Local Institution - 0050, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Local Institution - 0050

Shanghai, Shanghai, 200032

Site Contact

Site 0050

[email protected]

8559073286

Local Institution - 0051, Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

Local Institution - 0051

Hangzhou, Zhejiang, 310003

Site Contact

Site 0051

[email protected]

8559073286

Fakultni nemocnice Olomouc, Olomouc, Olomoucký Kraj, Czechia

Status

Recruiting

Address

Fakultni nemocnice Olomouc

Olomouc, Olomoucký Kraj, 779 00

Site Contact

Katerina Bouchalova, Site 0003

[email protected]

+420602668887

Fakultni nemocnice v Motole, Praha, Praha 5, Czechia

Status

Recruiting

Address

Fakultni nemocnice v Motole

Praha, Praha 5, 150 06

Site Contact

Rudolf Horvath, Site 0002

[email protected]

420727812317

Local Institution - 0063, Erlangen, Germany

Status

Not yet recruiting

Address

Local Institution - 0063

Erlangen, , 91054

Site Contact

Site 0063

[email protected]

8559073286

Local Institution - 0026, Hamburg, Germany

Status

Not yet recruiting

Address

Local Institution - 0026

Hamburg, , 22081

Site Contact

Site 0026

[email protected]

8559073286

Local Institution - 0025, Hannover, Germany

Status

Not yet recruiting

Address

Local Institution - 0025

Hannover, , 30625

Site Contact

Site 0025

[email protected]

8559073286

Local Institution - 0005, Napoli, Campania, Italy

Status

Not yet recruiting

Address

Local Institution - 0005

Napoli, Campania, 80131

Site Contact

Site 0005

[email protected]

8559073286

Firenze, Toscana, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Meyer IRCCS

Firenze, Toscana, 50139

Site Contact

Gabriele Simonini, Site 0004

[email protected]

+393297973141

Local Institution - 0017, San Juan, Puerto Rico

Status

Not yet recruiting

Address

Local Institution - 0017

San Juan, , 00917

Site Contact

Site 0017

[email protected]

8559073286

Local Institution - 0067, Cluj-Napoca, Cluj, Romania

Status

Not yet recruiting

Address

Local Institution - 0067

Cluj-Napoca, Cluj, 400177

Site Contact

Site 0067

[email protected]

8559073286

Local Institution - 0048, Iasi, Iași, Romania

Status

Withdrawn

Address

Local Institution - 0048

Iasi, Iași, 700135

Sc Medaudio-Optica Srl, Râmnicu Vâlcea, Vâlcea, Romania

Status

Recruiting

Address

Sc Medaudio-Optica Srl

Râmnicu Vâlcea, Vâlcea, 247065

Site Contact

RAZVAN IONITESCU, Site 0040

[email protected]

0040722557297

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035

Site Contact

Mireia Corbeto, Site 0046

[email protected]

667517630

Hospital Universitario Ramón y Cajal, Madrid, Madrid, Comunidad De, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad De, 28034

Site Contact

Alina Lucica Boteanu, Site 0041

[email protected]

+34913368571

Hospital Universitari i Politecnic La Fe, València, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

València, , 46026

Site Contact

LUCIA LACRUZ PEREZ, Site 0042

[email protected]

+34961244792

Local Institution - 0043, Istanbul- Fatih, İstanbul, Turkey

Status

Not yet recruiting

Address

Local Institution - 0043

Istanbul- Fatih, İstanbul, 34098

Site Contact

Site 0043

[email protected]

8559073286

Local Institution - 0061, Ankara, Turkey

Status

Not yet recruiting

Address

Local Institution - 0061

Ankara, , 06170

Site Contact

Site 0061

[email protected]

8559073286

Local Institution - 0044, Ankara, Turkey

Status

Not yet recruiting

Address

Local Institution - 0044

Ankara, , 06230

Site Contact

Site 0044

[email protected]

8559073286

Local Institution - 0045, Istanbul, Turkey

Status

Not yet recruiting

Address

Local Institution - 0045

Istanbul, , 34766

Site Contact

Site 0045

[email protected]

8559073286