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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502519-13 | Other Identifier | EU CTR |
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The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment deucravacitinib standard dose | Experimental |
| |
| Active treatment deucravacitinib half-standard dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observed average concentration at steady state for deucravacitinib at Week 2 | Part A | Week 2 |
| Maximum observed plasma concentration at steady state for deucravacitinib at Week 2 | Part A | Week 2 |
| Trough observed plasma concentration for deucravacitinib at Week 2 | Part A | Week 2 |
| Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 | Part B | Week 16 |
| Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 | Part B | Week 16 |
| Incidence of Adverse Events (AEs) | Long-term extension (LTE) Period | Up to 316 weeks |
| Incidence of serious adverse events (SAEs) | LTE Period | Up to 316 weeks |
| Monitoring of growth: Body weight | LTE Period | Up to 316 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Part A and Part B | Up to Week 52 |
| Incidence of serious adverse events (SAEs) | Part A and Part B | Up to Week 52 |
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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 |
|---|---|---|---|---|---|---|
| Instituto de Neumonologia Y Dermatologia | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | 1425 | Argentina |
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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 matching deucravacitinib | Other | Specified dose on specified days |
|
| Monitoring of growth: Height |
LTE Period |
| Up to 316 weeks |
| Monitoring of growth: Tanner staging (sexual maturation) | LTE Period | Up to 316 weeks |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in lymphocyte subsets and function | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in cytokine levels | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in physical examination findings | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in vital signs: Body temperature | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure | Part A and Part B | Up to Week 52 |
| Incidence of clinically significant changes in vital signs: Heart rate | Part A and Part B | Up to Week 52 |
| Monitoring of growth: Body weight | Part A and Part B | Up to Week 52 |
| Monitoring of growth: Height | Part A and Part B | Up to Week 52 |
| Monitoring of growth: Tanner staging (sexual maturation) | Part A and Part B | Up to Week 52 |
| Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo | Part B | Week 16 |
| Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo | Part B | Week 16 |
| Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Proportion of subjects achieving Juvenile Idiopathic Arthritis and the American College of Rheumatology 30 (JIA-ACR 30) response at Week 16 for subjects with confirmed JPsA prior to baseline | Part B JIA-ACR 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo | Week 16 |
| Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 |
| Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 | Part B | Week 16 |
| Observed average concentration at steady state for deucravacitinib at Week 16 | Part B | Week 16 |
| Maximum observed plasma concentration at steady state for deucravacitinib at Week 16 | Part B | Week 16 |
| Trough observed plasma concentration for deucravacitinib at Week 16 | Part B | Week 16 |
| Proportion of participants with 75% improvement in PASI (PASI 75) over time | LTE Period | Up to 316 weeks |
| Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time | LTE Period | Up to 316 weeks |
| Psoriahue | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1425DKG | Argentina |
|
| CONEXA Investigacion Clinica S.A. | Recruiting | Buenos Aires | 1012 | Argentina |
|
| Centro de Investigaciones Metabólicas (CINME) | Recruiting | Buenos Aires | C1056ABI | Argentina |
|
| Hospital Italiano de Buenos Aires | Recruiting | CABA | 1199 | Argentina |
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| Consultora Integral de Salud | Recruiting | Córdoba | 5004 | Argentina |
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| The Skin Hospital | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
|
| Local Institution - 0002 | Withdrawn | Westmead | New South Wales | 2145 | Australia |
| Queensland Children's Hospital | Recruiting | Brisbane | Queensland | 4101 | Australia |
|
| Veracity Clinical Research | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
|
| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Local Institution - 0001 | Completed | Melbourne | Victoria | 3995 | Australia |
| Centro de Pesquisas da Clínica IBIS | Recruiting | Salvador | Estado de Bahia | 41820-020 | Brazil |
|
| Hospital Moinhos de Vento | Recruiting | Porto Alegre | Rio Grande do Sul | 90560-032 | Brazil |
|
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP | Recruiting | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
|
| Local Institution - 0083 | Not yet recruiting | Rio de Janeiro | 22470-220 | Brazil |
|
| Local Institution - 0067 | Withdrawn | São Paulo | 05403-000 | Brazil |
| Local Institution - 0010 | Completed | Calgary | Alberta | T2J 7E1 | Canada |
| Alberta Dermasurgery Centre | Recruiting | Edmonton | Alberta | T6G 1C3 | Canada |
|
| Local Institution - 0039 | Withdrawn | Hamilton | Ontario | L8N 1Y2 | Canada |
| Lynderm Research Inc. | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| Centre Hospitalier de Calais | Recruiting | Calais | 62107 | France |
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| Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology | Recruiting | Dijon | 21000 | France |
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| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet | Recruiting | Nice | 06202 | France |
|
| Local Institution - 0021 | Completed | Paris | 75019 | France |
| Universitätsklinikum Münster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
|
| Universitätsmedizin Johannes Gutenberg Universität Mainz | Recruiting | Mainz | Rhineland-Palatinate | 55131 | Germany |
|
| Universitaetsklinikum Carl Gustav Carus Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
|
| Charité Universitaetsmedizin Berlin - Campus Mitte | Recruiting | Berlin | 10117 | Germany |
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| Kath. Kinderkrankenhaus Wilhelmstift | Recruiting | Hamburg | 22149 | Germany |
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| Nagoya City University Hospital | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
|
| Fukuoka University Hospital | Recruiting | Fukuoka, Jonan-Ku | Fukuoka | 814-0180 | Japan |
|
| Local Institution - 0040 | Withdrawn | Isehara | Kanagawa | 259-1193 | Japan |
| Mie University Hospital | Recruiting | Tsu | Mie-ken | 514-8507 | Japan |
|
| Teikyo University Hospital | Recruiting | Itabashi-ku | Tokyo | 173-8606 | Japan |
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| Tokyo Medical University Hospital | Recruiting | Shinjuku-ku | Tokyo | 160-0023 | Japan |
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| Nippon Life Hospital | Recruiting | Osaka | 550-0006 | Japan |
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| Crea de Guadalajara | Recruiting | Guadalajara | Jalisco | 44600 | Mexico |
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| Grupo Clínico CATEI S.C. | Recruiting | Guadalajara | Jalisco | 44638 | Mexico |
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| RM Pharma Specialists | Recruiting | Mexico City | Mexico City | 03100 | Mexico |
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| Arké SMO S.A de C.V | Recruiting | Veracruz | 91910 | Mexico |
|
| Local Institution - 0011 | Completed | Krakow | 30-438 | Poland |
| Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak | Recruiting | Lodz | 90-436 | Poland |
|
| Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii | Recruiting | Warsaw | 02-507 | Poland |
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| WroMedica | Recruiting | Wroclaw | 51-620 | Poland |
|
| Local Institution - 0080 | Withdrawn | Bucharest | Bucharest | 012292 | Romania |
| Local Institution - 0081 | Withdrawn | Bucharest | Bucharest | 020125 | Romania |
| Local Institution - 0088 | Withdrawn | Bucharest | Bucharest | 020762 | Romania |
| CCBR Clinical Research | Recruiting | Bucharest | Bucharest | 30463 | Romania |
|
| Lotus-Med Tunari | Recruiting | Bucharest | 020528 | Romania |
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| Spitalul clinic de urgenta pentru copii Sf. Maria | Recruiting | Iași | 700309 | Romania |
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| Spitalul Clinic Judetean Mures | Recruiting | Târgu Mureş | 540342 | Romania |
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| Local Institution - 0048 | Completed | Seoul | Seoul-teukbyeolsi [Seoul] | 02447 | South Korea |
| Local Institution - 0047 | Completed | Seoul | Seoul-teukbyeolsi [Seoul] | 03722 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
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| Hospital General Universitario de Alicante-Dermatology | Recruiting | Alicante | 03010 | Spain |
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| OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology | Recruiting | Barakaldo | 48903 | Spain |
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| Hospital Sant Joan de Déu-URC Dermatology | Recruiting | Esplugues de Llobregat | 08950 | Spain |
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| Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología | Recruiting | Las Palmas de GC | 35019 | Spain |
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| Hospital Universitario 12 de Octubre-DERMATOLOGY | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario La Paz-UCICEC/DERMA | Recruiting | Madrid | 28046 | Spain |
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| Mounts Bay Medical | Recruiting | Connor Downs | TR27 5DT | United Kingdom |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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