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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517262-41 | Other Identifier | EU CTR | |
| U1111-1311-9059 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first flare during the withdrawal period | From week 16 up to week 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough concentration at steady state (Cminss) | At week 16 | |
| Time-averaged steady-state concentration (Cavgss) | At week 16 | |
| Steady-state maximum observed concentration (Cmaxss) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0038 | Withdrawn | Lancaster | California | 93534 | United States | |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Placebo |
| Other |
Specified dose on specified days |
|
| At week 16 |
| Number of participants with flare during the withdrawal period | From week 16 up to week 42 |
| Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8) | Through week 16 and up to week 42 |
| Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1) | Through week 16 and up to week 42 |
| Number of participants attaining clinical remission for at least 6 consecutive months | At week 42 |
| Number of participants achieving psoriasis area and severity index (PASI) 75 | At week 42 |
| Number of participants with adverse events (AEs) | Up to week 42 |
| Number of participants with adverse event of special interest (AESIs) | Up to week 42 |
| Number of participants with AEs leading to discontinuation | Up to week 42 |
| Number of participants with serious adverse events (SAEs) | Up to week 42 |
| Number of participants with Uveitis | Up to week 42 |
| Number of participants achieving each of juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) (30/50/70/90) | Through week 16 and up to week 42 |
| Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Core Criteria | Through week 16 and up to week 42 |
| Number of participants for each assessment who evaluate palatability scale as ≥ 3 (good or better), swallowability scale as ≤ 4 (neutral or easier), and taste scales (Sweetness, Bitterness, Flavor, and Overall Taste) as "None" or "Weak" | At week 16 |
| Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using JIA-ACR 30 | At week 16 |
| Local Institution - 0020 |
| Withdrawn |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Local Institution - 0023 | Withdrawn | Indianapolis | Indiana | 46202 | United States |
| Local Institution - 0059 | Withdrawn | North New Hyde Park | New York | 11040 | United States |
| Local Institution - 0065 | Withdrawn | Cincinnati | Ohio | 45229 | United States |
| Local Institution - 0066 | Withdrawn | Cleveland | Ohio | 44109 | United States |
| Local Institution - 0036 | Withdrawn | Austin | Texas | 78723 | United States |
| Centro de Oncologia Leonardo Da Vinci - ATO Terapias | Recruiting | Fortaleza | Ceará | 60140-025 | Brazil |
|
| Local Institution - 0032 | Withdrawn | Cuiabá | Mato Grosso | 78020-500 | Brazil |
| Santa Casa de Misericordia de Belo Horizonte | Recruiting | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
|
| Local Institution - 0013 | Withdrawn | Curitiba | Paraná | 80250-060 | Brazil |
| Local Institution - 0072 | Not yet recruiting | Curitiba | Paraná | 80250-060 | Brazil |
|
| Hospital Das Clinicas Ufpe | Recruiting | Recife | Pernambuco | 50670-420 | Brazil |
|
| Local Institution - 0033 | Withdrawn | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| LMK Serviços Médicos S/S | Recruiting | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
|
| Local Institution - 0073 | Not yet recruiting | Vila Clementino | São Paulo-SP | 04038-002 | Brazil |
|
| Local Institution - 0027 | Not yet recruiting | Rio de Janeiro | 21941-612 | Brazil |
|
| Santa Casa Instituto de Pesquisa | Recruiting | São Paulo | 01223-001 | Brazil |
|
| Local Institution - 0010 | Withdrawn | São Paulo | 04022-001 | Brazil |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD | Recruiting | Plovdiv | 4002 | Bulgaria |
|
| Local Institution - 0069 | Not yet recruiting | Sofia | 1309 | Bulgaria |
|
| Local Institution - 0062 | Withdrawn | Sofia | 1797 | Bulgaria |
| Local Institution - 0074 | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
|
| Local Institution - 0049 | Not yet recruiting | Beijing | Beijing Municipality | 100045 | China |
|
| The Children's Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400065 | China |
|
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Childrens Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210008 | China |
|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
|
| The Children's Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310057 | China |
|
| Children's Hospital of Fudan University | Recruiting | Shanghai | 201102 | China |
|
| Fakultni nemocnice Olomouc | Recruiting | Olomouc | Olomouc Region | 779 00 | Czechia |
|
| Fakultni nemocnice v Motole | Recruiting | Prague | Praha 5 | 150 06 | Czechia |
|
| Kinderklinik des Uni-Klinikums Erlangen | Recruiting | Erlangen | 91054 | Germany |
|
| Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Recruiting | Hamburg | 22081 | Germany |
|
| University of Naples Federico II | Recruiting | Naples | Campania | 80131 | Italy |
|
| Azienda Ospedaliera Universitaria Meyer IRCCS | Recruiting | Florence | Tuscany | 50139 | Italy |
|
| Local Institution - 0017 | Withdrawn | San Juan | 00917 | Puerto Rico |
| Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca | Recruiting | Cluj-Napoca | Cluj | 400177 | Romania |
|
| Local Institution - 0048 | Withdrawn | Iași | Iaşi | 700135 | Romania |
| Sc Medaudio-Optica Srl | Recruiting | Râmnicu Vâlcea | Vâlcea County | 247065 | Romania |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Madrid, Comunidad de | 28034 | Spain |
|
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
|
| Istanbul Universitesi Cerrahpasa | Recruiting | Istanbul- Fatih | Istanbul | 34098 | Turkey (Türkiye) |
|
| Local Institution - 0061 | Not yet recruiting | Ankara | 06170 | Turkey (Türkiye) |
|
| Local Institution - 0044 | Not yet recruiting | Ankara | 06230 | Turkey (Türkiye) |
|
| Umraniye Training and Research Hospital | Recruiting | Istanbul | 34766 | Turkey (Türkiye) |
|
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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