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 (Türkiye), 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 5364940, California 5332921

Status

Not yet recruiting

Address

Local Institution - 0038

Lancaster 5364940, California 5332921, 93534

Site Contact

Site 0038

[email protected]

8559073286

Local Institution - 0020, Chicago 4887398, Illinois 4896861

Status

Not yet recruiting

Address

Local Institution - 0020

Chicago 4887398, Illinois 4896861, 60611

Site Contact

Site 0020

[email protected]

8559073286

Local Institution - 0023, Indianapolis 4259418, Indiana 4921868

Status

Not yet recruiting

Address

Local Institution - 0023

Indianapolis 4259418, Indiana 4921868, 46202

Site Contact

Site 0023

[email protected]

8559073286

Local Institution - 0059, North New Hyde Park 5129147, New York 5128638

Status

Not yet recruiting

Address

Local Institution - 0059

North New Hyde Park 5129147, New York 5128638, 11040

Site Contact

Site 0059

[email protected]

8559073286

Local Institution - 0065, Cincinnati 4508722, Ohio 5165418

Status

Not yet recruiting

Address

Local Institution - 0065

Cincinnati 4508722, Ohio 5165418, 45229

Site Contact

Site 0065

[email protected]

8559073286

Local Institution - 0066, Cleveland 5150529, Ohio 5165418

Status

Not yet recruiting

Address

Local Institution - 0066

Cleveland 5150529, Ohio 5165418, 44109

Site Contact

Site 0066

[email protected]

8559073286

Local Institution - 0036, Austin 4671654, Texas 4736286

Status

Not yet recruiting

Address

Local Institution - 0036

Austin 4671654, Texas 4736286, 78723

Site Contact

Site 0036

[email protected]

8559073286

International Sites

Local Institution - 0032, Cuiabá 3465038, Mato Grosso 3457419, Brazil

Status

Withdrawn

Address

Local Institution - 0032

Cuiabá 3465038, Mato Grosso 3457419, 78020-500

Local Institution - 0030, Belo Horizonte 3470127, Minas Gerais 3457153, Brazil

Status

Not yet recruiting

Address

Local Institution - 0030

Belo Horizonte 3470127, Minas Gerais 3457153, 30150-221

Site Contact

Site 0030

[email protected]

8559073286

Local Institution - 0007, Recife 3390760, Pernambuco 3392268, Brazil

Status

Not yet recruiting

Address

Local Institution - 0007

Recife 3390760, Pernambuco 3392268, 50670-420

Site Contact

Site 0007

[email protected]

8559073286

Local Institution - 0033, Porto Alegre 3452925, Rio Grande do Sul 3451133, Brazil

Status

Not yet recruiting

Address

Local Institution - 0033

Porto Alegre 3452925, Rio Grande do Sul 3451133, 90020-090

Site Contact

Site 0033

[email protected]

8559073286

Local Institution - 0008, Porto Alegre 3452925, Rio Grande do Sul 3451133, Brazil

Status

Not yet recruiting

Address

Local Institution - 0008

Porto Alegre 3452925, Rio Grande do Sul 3451133, 90480-000

Site Contact

Site 0008

[email protected]

8559073286

Local Institution - 0027, Rio de Janeiro 3451190, Brazil

Status

Not yet recruiting

Address

Local Institution - 0027

Rio de Janeiro 3451190, , 21941-612

Site Contact

Site 0027

[email protected]

8559073286

Local Institution - 0047, São Paulo 3448439, Brazil

Status

Not yet recruiting

Address

Local Institution - 0047

São Paulo 3448439, , 01223-001

Site Contact

Site 0047

[email protected]

8559073286

Local Institution - 0010, São Paulo 3448439, Brazil

Status

Withdrawn

Address

Local Institution - 0010

São Paulo 3448439, , 04022-001

Plovdiv 728193, Bulgaria

Status

Recruiting

Address

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv 728193, , 4002

Site Contact

Krastina Stefanova-Kelly, Site 0054

[email protected]

+359876324578

Local Institution - 0062, Sofia 727011, Bulgaria

Status

Not yet recruiting

Address

Local Institution - 0062

Sofia 727011, , 1797

Site Contact

Site 0062

[email protected]

8559073286

Local Institution - 0049, Beijing 1816670, Beijing Municipality 2038349, China

Status

Not yet recruiting

Address

Local Institution - 0049

Beijing 1816670, Beijing Municipality 2038349, 100045

Site Contact

Site 0049

[email protected]

8559073286

Local Institution - 0056, Chongqing 1814906, Chongqing Municipality 1814905, China

Status

Not yet recruiting

Address

Local Institution - 0056

Chongqing 1814906, Chongqing Municipality 1814905, 400065

Site Contact

Site 0056

[email protected]

8559073286

Local Institution - 0060, Guangzhou 1809858, Guangdong 1809935, China

Status

Not yet recruiting

Address

Local Institution - 0060

Guangzhou 1809858, Guangdong 1809935, 510620

Site Contact

Site 0060

[email protected]

8559073286

Local Institution - 0052, Nanjing 1799962, Jiangsu 1806260, China

Status

Not yet recruiting

Address

Local Institution - 0052

Nanjing 1799962, Jiangsu 1806260, 210008

Site Contact

Site 0052

[email protected]

8559073286

Local Institution - 0053, Changchun 2038180, Jilin 2036500, China

Status

Not yet recruiting

Address

Local Institution - 0053

Changchun 2038180, Jilin 2036500, 130000

Site Contact

Site 0053

[email protected]

8559073286

Local Institution - 0050, Shanghai 1796236, Shanghai Municipality 1796231, China

Status

Not yet recruiting

Address

Local Institution - 0050

Shanghai 1796236, Shanghai Municipality 1796231, 200032

Site Contact

Site 0050

[email protected]

8559073286

Local Institution - 0051, Hangzhou 1808926, Zhejiang 1784764, China

Status

Not yet recruiting

Address

Local Institution - 0051

Hangzhou 1808926, Zhejiang 1784764, 310003

Site Contact

Site 0051

[email protected]

8559073286

Fakultni nemocnice Olomouc, Olomouc 3069011, Olomoucký kraj 3339542, Czechia

Status

Recruiting

Address

Fakultni nemocnice Olomouc

Olomouc 3069011, Olomoucký kraj 3339542, 779 00

Site Contact

Katerina Bouchalova, Site 0003

[email protected]

+420602668887

Fakultni nemocnice v Motole, Prague 3067696, Praha 5, Czechia

Status

Recruiting

Address

Fakultni nemocnice v Motole

Prague 3067696, Praha 5, 150 06

Site Contact

Rudolf Horvath, Site 0002

[email protected]

420727812317

Kinderklinik des Uni-Klinikums Erlangen, Erlangen 2929567, Germany

Status

Recruiting

Address

Kinderklinik des Uni-Klinikums Erlangen

Erlangen 2929567, , 91054

Site Contact

Tobias Krickau, Site 0063

[email protected]

091318533118

Hamburg 2911298, Germany

Status

Recruiting

Address

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg 2911298, , 22081

Site Contact

Ivan Foeldvari, Site 0026

[email protected]

00494020923698

Local Institution - 0025, Hanover 2910831, Germany

Status

Not yet recruiting

Address

Local Institution - 0025

Hanover 2910831, , 30625

Site Contact

Site 0025

[email protected]

8559073286

University of Naples Federico II, Napoli 9031661, Campania 3181042, Italy

Status

Recruiting

Address

University of Naples Federico II

Napoli 9031661, Campania 3181042, 80131

Site Contact

Roberta Naddei, Site 0005

[email protected]

00393272022085

Florence 3176959, Tuscany 3165361, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence 3176959, Tuscany 3165361, 50139

Site Contact

Gabriele Simonini, Site 0004

[email protected]

+393297973141

Local Institution - 0017, San Juan 4568127, Puerto Rico

Status

Not yet recruiting

Address

Local Institution - 0017

San Juan 4568127, , 00917

Site Contact

Site 0017

[email protected]

8559073286

Cluj-Napoca 681290, Cluj 681291, Romania

Status

Recruiting

Address

Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

Cluj-Napoca 681290, Cluj 681291, 400177

Site Contact

Mihaela Sparchez, Site 0067

[email protected]

+40723400453

Local Institution - 0048, Iași 675810, Iaşi 675809, Romania

Status

Withdrawn

Address

Local Institution - 0048

Iași 675810, Iaşi 675809, 700135

Sc Medaudio-Optica Srl, Râmnicu Vâlcea 668872, Vâlcea County 662892, Romania

Status

Recruiting

Address

Sc Medaudio-Optica Srl

Râmnicu Vâlcea 668872, Vâlcea County 662892, 247065

Site Contact

RAZVAN IONITESCU, Site 0040

[email protected]

0040722557297

Hospital Universitari Vall d'Hebron, Barcelona 3128760, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona 3128760, Barcelona [Barcelona], 08035

Site Contact

Mireia Corbeto, Site 0046

[email protected]

667517630

Hospital Universitario Ramón y Cajal, Madrid 3117735, Madrid, Comunidad de, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid 3117735, Madrid, Comunidad de, 28034

Site Contact

Alina Lucica Boteanu, Site 0041

[email protected]

+34913368571

Hospital Universitari i Politecnic La Fe, Valencia 2509954, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

Valencia 2509954, , 46026

Site Contact

LUCIA LACRUZ PEREZ, Site 0042

[email protected]

+34961244792

Local Institution - 0043, Istanbul- Fatih, Istanbul 745042, Turkey (Türkiye)

Status

Not yet recruiting

Address

Local Institution - 0043

Istanbul- Fatih, Istanbul 745042, 34098

Site Contact

Site 0043

[email protected]

8559073286

Local Institution - 0061, Ankara 323786, Turkey (Türkiye)

Status

Not yet recruiting

Address

Local Institution - 0061

Ankara 323786, , 06170

Site Contact

Site 0061

[email protected]

8559073286

Local Institution - 0044, Ankara 323786, Turkey (Türkiye)

Status

Not yet recruiting

Address

Local Institution - 0044

Ankara 323786, , 06230

Site Contact

Site 0044

[email protected]

8559073286

Local Institution - 0045, Istanbul 745044, Turkey (Türkiye)

Status

Not yet recruiting

Address

Local Institution - 0045

Istanbul 745044, , 34766

Site Contact

Site 0045

[email protected]

8559073286