Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506296-97 | Other Identifier | EU CTR | |
| U1111-1289-8030 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Deucravacitinib | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) | At week 16 | |
| Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline | At week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving at least 90% improvement in PASI (PASI 90) | At week 16 | |
| Change from baseline in PASI | At week 16 | |
| Change from baseline in body surface area (BSA) involvement |
Not provided
Inclusion Criteria
Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
Participants must have moderate to severe psoriasis defined by:.
i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
i) Is not an individual of childbearing potential (IOCBP).
ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| 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 - 0261 | Not yet recruiting | Birmingham | Alabama | 35203 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Specified dose on specified days |
|
| At week 16 |
| Change from baseline in worst itch numeric rating scale (WI-NRS) | At week 16 |
| Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4) | At week 16 |
| Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score | At week 16 |
| Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2) | At week 16 |
| Number of participants with treatment emergent adverse events | Up to 5 years |
| Number of participants with serious adverse events | Up to 5 years |
| Number of participants with clinically significant changes in laboratory parameters | Up to 5 years |
| Number of participants with clinically significant changes in physical examinations | Up to 5 years |
| Number of participants with clinically significant changes in vital signs | Up to 5 years |
| Number of participants with protective titers of antibodies to measles | At week 16 |
| Number of participants with protective titers of antibodies to tetanus | At week 16 |
| Number of participants with protective titers of antibodies to pertussis | At week 16 |
| Body weight | Up to 5 years |
| Height | Up to 5 years |
| Sexual maturation | Up to 5 years |
| Local Institution - 0041 | Not yet recruiting | Birmingham | Alabama | 35243 | United States |
|
| Local Institution - 0053 | Active, not recruiting | Phoenix | Arizona | 85006 | United States |
| Local Institution - 0025 | Not yet recruiting | Fountain Valley | California | 92708 | United States |
|
| Center For Dermatology Clinical Research, Inc. | Recruiting | Fremont | California | 94538 | United States |
|
| Dermatology Research Associates | Recruiting | Los Angeles | California | 90045 | United States |
|
| Northridge Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
|
| Local Institution - 0077 | Not yet recruiting | Sacramento | California | 95814 | United States |
|
| Golden State Dermatology - Walnut Creek - Ygnacio Valley Road | Recruiting | Walnut Creek | California | 94598 | United States |
|
| Paradigm Clinical Research, LLC | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
|
| Local Institution - 0021 | Not yet recruiting | Clearwater | Florida | 33756 | United States |
|
| Life Clinical Trials | Recruiting | Margate | Florida | 33063 | United States |
|
| Skin Research of South Florida | Recruiting | Miami | Florida | 33173 | United States |
|
| Wellness Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | United States |
|
| MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research | Recruiting | Tampa | Florida | 33607 | United States |
|
| USF Health | Recruiting | Tampa | Florida | 33612 | United States |
|
| Dermatology Affiliates Research Institute | Recruiting | Atlanta | Georgia | 30305 | United States |
|
| Advanced Medical Research, PC. | Recruiting | Sandy Springs | Georgia | 30328 | United States |
|
| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
|
| Kentucky Advanced Medical Research LLC | Recruiting | Murray | Kentucky | 42071 | United States |
|
| Local Institution - 0202 | Not yet recruiting | Metairie | Louisiana | 70001 | United States |
|
| Dermatology and Skin Cancer Specialists, LLC | Recruiting | Rockville | Maryland | 20850 | United States |
|
| Kuchnir Dermatology & Dermatologic Surgery | Recruiting | Milford | Massachusetts | 01757 | United States |
|
| Local Institution - 0095 | Not yet recruiting | Detroit | Michigan | 48201 | United States |
|
| Local Institution - 0233 | Not yet recruiting | Columbia | Missouri | 65201 | United States |
|
| Local Institution - 0278 | Not yet recruiting | Columbia | Missouri | 65212 | United States |
|
| Local Institution - 0266 | Not yet recruiting | Lee's Summit | Missouri | 64064 | United States |
|
| JDR Dermatology Research | Recruiting | Las Vegas | Nevada | 89148 | United States |
|
| Local Institution - 0283 | Not yet recruiting | Clifton | New Jersey | 07013 | United States |
|
| Local Institution - 0281 | Not yet recruiting | Robbinsville | New Jersey | 08691 | United States |
|
| Local Institution - 0205 | Not yet recruiting | New York | New York | 10075 | United States |
|
| Local Institution - 0166 | Not yet recruiting | The Bronx | New York | 10467 | United States |
|
| Local Institution - 0234 | Completed | Hickory | North Carolina | 28602 | United States |
| Apex Clinical Research Center - Canton | Recruiting | Canton | Ohio | 44716 | United States |
|
| Local Institution - 0271 | Not yet recruiting | Columbus | Ohio | 43228 | United States |
|
| Local Institution - 0275 | Not yet recruiting | Lorain | Ohio | 44053 | United States |
|
| Apex Clinical Research Center | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
|
| Paddington Testing Company | Recruiting | Philadelphia | Pennsylvania | 19103 | United States |
|
| ObjectiveHealth - Goodlettsville Dermatology Research | Recruiting | Goodlettsville | Tennessee | 37072 | United States |
|
| Local Institution - 0248 | Completed | Nashville | Tennessee | 37205 | United States |
| Texas Dermatology and Laser Specialists | Recruiting | San Antonio | Texas | 78218 | United States |
|
| Local Institution - 0280 | Not yet recruiting | Southlake | Texas | 76092 | United States |
|
| Local Institution - 0045 | Not yet recruiting | Norfolk | Virginia | 23502 | United States |
|
| Frontier Derm Partners | Recruiting | Mill Creek | Washington | 98012 | United States |
|
| Local Institution - 0264 | Not yet recruiting | Spokane | Washington | 99204 | United States |
|
| Instituto de Neumonologia Y Dermatologia | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | 1425 | Argentina |
|
| Psoriahue | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1425DKG | Argentina |
|
| Centro de Investigaciones Médicas Tucuman | Recruiting | SAN M. de Tucuman | Tucumán Province | T4000AXL | Argentina |
|
| CONEXA Investigacion Clinica S.A. | Recruiting | Buenos Aires | 1012 | Argentina |
|
| Hospital Italiano de Buenos Aires | Recruiting | Buenos Aires | 1181 | Argentina |
|
| Hospital de Niños Dr. Ricardo Gutiérrez | Recruiting | Buenos Aires | 1425 | Argentina |
|
| Derma Internacional | Recruiting | Buenos Aires | 1426 | Argentina |
|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | Bruxelles-Capitale, Région de | 1200 | Belgium |
|
| Local Institution - 0210 | Withdrawn | Brussels | Bruxelles-Capitale, Région de | 1200 | Belgium |
| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
|
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Recruiting | Liège | 4000 | Belgium |
|
| Local Institution - 0137 | Not yet recruiting | Salvador | Estado de Bahia | 41820-020 | Brazil |
|
| Local Institution - 0182 | Not yet recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
|
| Hospital Moinhos de Vento | Recruiting | Porto Alegre | Rio Grande do Sul | 90560-032 | Brazil |
|
| Local Institution - 0140 | Not yet recruiting | Barretos | São Paulo | 14784400 | Brazil |
|
| Local Institution - 0163 | Not yet recruiting | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
|
| Local Institution - 0170 | Not yet recruiting | São Paulo | 05403-000 | Brazil |
|
| Alberta Dermasurgery Centre | Recruiting | Edmonton | Alberta | T6G 1C3 | Canada |
|
| Local Institution - 0164 | Not yet recruiting | Winnipeg | Manitoba | R3C 0N2 | Canada |
|
| Skincare Studio | Recruiting | St. John's | Newfoundland and Labrador | A1E 1V4 | Canada |
|
| DermEffects | Recruiting | London | Ontario | N6H 5L5 | Canada |
|
| The Centre for Dermatology | Recruiting | Richmond Hill | Ontario | L4B 1A5 | Canada |
|
| AvantDerm | Recruiting | Toronto | Ontario | M5A 3R6 | Canada |
|
| Local Institution - 0240 | Not yet recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|
| Local Institution - 0142 | Not yet recruiting | Montreal | Quebec | H3T 1C5 | Canada |
|
| Beijing Children's hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100045 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100091 | China |
|
| Guangdong Province Dermatology Hospital | Recruiting | Guangzhou | Guangdong | 510018 | China |
|
| The University of Hong Kong-Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518053 | China |
|
| The Affiliated Hospital of Hebei University of Engineering | Recruiting | Handan | Hebei | 56029 | China |
|
| Local Institution - 0227 | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
|
| Hunan Children's Hospital | Recruiting | Changsha | Hunan | 410007 | China |
|
| Local Institution - 0265 | Not yet recruiting | Jinan | Shandong | 250022 | China |
|
| Shanghai Skin Disease Hospital | Recruiting | Shanghai | Shanghai Municipality | 200443 | China |
|
| Local Institution - 0228 | Not yet recruiting | Chengdu | Sichuan | 610091 | China |
|
| The First People's Hospital of Hangzhou | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| Local Institution - 0225 | Not yet recruiting | Medellín | Antioquia | 050012 | Colombia |
|
| Local Institution - 0124 | Not yet recruiting | Medellín | Antioquia | 50021 | Colombia |
|
| Local Institution - 0167 | Not yet recruiting | Barranquilla | Atlántico | 080002 | Colombia |
|
| Local Institution - 0125 | Not yet recruiting | Bogota | Cundinamarca | 111 411 | Colombia |
|
| Universitätsklinikum Münster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
|
| BAG Drs. Med. Quist PartG | Recruiting | Mainz | Rhineland-Palatinate | 55128 | Germany |
|
| Charité Universitaetsmedizin Berlin - Campus Mitte | Recruiting | Berlin | 10117 | Germany |
|
| Universitaetsklinikum Carl Gustav Carus Dresden | Recruiting | Dresden | 01307 | Germany |
|
| Universitaetsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
|
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Recruiting | Szeged | Csongrád megye | 6720 | Hungary |
|
| Clinexpert Kft. | Recruiting | Budapest | Pest County | 1033 | Hungary |
|
| Debreceni Egyetem Klinikai Kozpont | Recruiting | Debrecen | 4032 | Hungary |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Recruiting | Roma | 00168 | Italy |
|
| Local Institution - 0238 | Not yet recruiting | Zapopan | Jalisco | 45190 | Mexico |
|
| Local Institution - 0253 | Not yet recruiting | Mexico City | Mexico City | 06720 | Mexico |
|
| Local Institution - 0155 | Not yet recruiting | Monterrey | Nuevo León | 64718 | Mexico |
|
| Local Institution - 0259 | Not yet recruiting | Chihuahua City | 31217 | Mexico |
|
| Local Institution - 0257 | Not yet recruiting | Mérida | 97070 | Mexico |
|
| Local Institution - 0258 | Not yet recruiting | Toluca | 50010 | Mexico |
|
| Local Institution - 0096 | Not yet recruiting | Veracruz | 91910 | Mexico |
|
| Local Institution - 0177 | Withdrawn | Lublin | Lublin Voivodeship | 20-573 | Poland |
| FutureMeds - Targowek | Recruiting | Warsaw | Masovian Voivodeship | 03-291 | Poland |
|
| SPECDERM Poznanska sp.j. | Recruiting | Bialystok | Podlaskie Voivodeship | 15-375 | Poland |
|
| Local Institution - 0282 | Not yet recruiting | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
|
| "DERMED" Centrum Medyczne Sp. z o.o. | Recruiting | Lodz | 90-265 | Poland |
|
| ETYKA Osrodek Badan Klinicznych | Recruiting | Olsztyn | 10-117 | Poland |
|
| Klinika Ambroziak Dermatologia | Recruiting | Warsaw | 02-953 | Poland |
|
| Royalderm Agnieszka Nawrocka | Recruiting | Warsaw | 02-962 | Poland |
|
| Local Institution - 0254 | Not yet recruiting | Bayamón | 00960 | Puerto Rico |
|
| Local Institution - 0008 | Not yet recruiting | Caguas | 00725 | Puerto Rico |
|
| GCM Medical Group, PSC - Hato Rey Site | Recruiting | San Juan | 00917 | Puerto Rico |
|
| Local Institution - 0174 | Withdrawn | Bucharest | Bucharest | 020125 | Romania |
| Lotus-Med Tunari | Recruiting | Bucharest | Bucharest | 020528 | Romania |
|
| Local Institution - 0213 | Withdrawn | Bucharest | Bucharest | 30463 | Romania |
| Policlinica Providența | Recruiting | Iași | 700259 | Romania |
|
| Centrul de Medicina de Familie | Recruiting | Iași | 700556 | Romania |
|
| New Derm Clinical SRL | Recruiting | Timișoara | 300757 | Romania |
|
| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | Barcelona [Barcelona] | 08950 | Spain |
|
| Local Institution - 0198 | Not yet recruiting | Barcelona | Catalunya [Cataluña] | 08041 | Spain |
|
| Grupo Dermatológico y Estético Pedro Jaén S.A | Recruiting | Madrid | 28002 | Spain |
|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
|
| CHUS - Hospital Clinico Universitario | Recruiting | Santiago de Compostela | 15706 | Spain |
|
| Chang Gung Memorial Hospital at Kaohsiung | Recruiting | Kaohsiung Niao Sung Dist | Kaohsiung | 83301 | Taiwan |
|
| Kaohsiung Veterans General Hospital | Recruiting | Kaohsiung City | 81362 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Chang Gung Medical Foundation-Linkou Branch | Recruiting | Taoyuan | 333 | Taiwan |
|
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D005076 | Exanthema |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
Not provided
Not provided