Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

Psoriasis Clinical Trial

— POETYK PSO-LTE  

Official title:

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036435
• Other study ID #: IM011-075
• Secondary ID: 2019-000612-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 12, 2019
• Est. completion date: July 26, 2026

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1452
• Est. completion date: July 26, 2026
• Est. primary completion date: July 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis

• Women must not be pregnant, lactating, or breastfeeding

Exclusion Criteria:

• Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.

• To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986165
Specified dose on specified days

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Local Institution - 0245	Box Hill	Victoria
Australia	Skin and Cancer Foundation	Carlton	Victoria
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	North Eastern Health Specialists	Hectorville	South Australia
Australia	St. George Dermatology & Skin Care Centre	Kogarah	New South Wales
Australia	Local Institution - 0251	Parkville	Victoria
Australia	Local Institution - 0247	Perth	Western Australia
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Local Institution - 0250	Westmead	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Canada	CCA Medical Research	Ajax	Ontario
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Stratica Medical	Edmonton	Alberta
Canada	Local Institution - 0090	London	Ontario
Canada	Mediprobe Research	London	Ontario
Canada	Lynderm Research	Markham	Ontario
Canada	DermEdge	Mississauga	Ontario
Canada	Docteur David Gratton Dermatologue	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Office of Dr. Niakosari Firouzeh	North York	Ontario
Canada	Institute of Cosmetic and Laser Surgery	Oakville	Ontario
Canada	Local Institution - 0088	Peterborough	Ontario
Canada	Local Institution - 0258	Quebec
Canada	Local Institution - 0082	Richmond Hill	Ontario
Canada	SkinFit MD Laser and Cosmetic Clinic	Surrey	British Columbia
Canada	Local Institution - 0132	Toronto	Ontario
Canada	Toronto Dermatology Centre	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	Kim Papp Clinical Research	Waterloo	Ontario
Canada	XLR8 Medical Research	Windsor	Ontario
Canada	Wiseman Dermatology Research	Winnipeg	Manitoba
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Dalian	Liaoning
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution - 0312	Nanjing	Jiangsu
China	Local Institution - 0292	Shanghai	Shanghai
China	Local Institution	Taiyuan	Shan1xi
China	Local Institution	Wuhan	Hubei
China	Local Institution	Wuhan	Hubei
Czechia	Nemocnice Jihlava	Jihlava 1
Czechia	Nemocnice Novy Jicin a.s.	Novy Jicin
Czechia	MUDr. Helena Korandova	Olomouc
Czechia	Fakultni Nemocnice Ostrava	Ostrava
Czechia	Sanatorium profesora Arenbergera	Praha 1
Czechia	Clintrial	Praha 10
Czechia	Krajska zdravotni - Masarykova nemocnice v Usti nad Labem	Usti nad Labem
Finland	Local Institution - 0279	Tampere
France	Centre Hospitalier Universitaire de Nice Hopital lArchet	Nice cedex 3
Germany	Licca Clinical Research Institute	Augsburg
Germany	Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus	Bochum
Germany	Hautarztpraxis Dr. Beatrice Gerlach	Dresden
Germany	Synexus Frankfurt Clinical Research	Frankfurt am Main
Germany	Local Institution - 0263	Hamburg
Germany	Dermakiel - Allergie Und Haut Centrum	Kiel
Germany	Praxis Dr. Beate Schwarz	Langenau
Germany	Praxis Dr. med. Wilfried Steinborn	Straubing
Germany	CentroDerm Privatklinik	Wuppertal
Hungary	Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Synexus Magyarorszag	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site	Debrecen
Hungary	Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula	Gyula
Hungary	Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat	Nyiregyhaza
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Allergo-Derm Bakos	Szolnok
Hungary	Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg	Zalaegerszeg
Israel	Local Institution - 0237	Haifa
Israel	Local Institution	Petah Tikva
Israel	Local Institution	Ramat Gan
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Tokai University Hospital	Isehara City	Kanagawa
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Teikyo University Hospital	Itabashi-Ku	Tokyo
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Kyoto University Hospital	Kyoto-City	Kyoto
Japan	Local Institution - 0066	Kyoto-city	Kyoto
Japan	Local Institution - 0072	Matsumoto	Nagano
Japan	The Jikei University Hospital	Minato-ku	Tokyo
Japan	Local Institution - 0065	Nagoya	Aichi
Japan	Local Institution - 0076	Nankoku	Kochi
Japan	Local Institution - 0067	Osaka
Japan	Local Institution - 0073	Osaka
Japan	Sapporo Skin Clinic	Sapporo	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Local Institution - 0062	Shinagawa	Tokyo
Japan	Japan Community Health Care Organization Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Mie University Hospital	Tsu	MIE
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Japan	Local Institution - 0075	Yokohama-Shi	Kanagawa
Korea, Republic of	Local Institution	Bucheon-si
Korea, Republic of	Local Institution - 0054	Busan
Korea, Republic of	Local Institution	Goyang-si
Korea, Republic of	Local Institution - 0310	Gwangju
Korea, Republic of	Local Institution	Hwaseong-si
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seongnam-si
Korea, Republic of	Local Institution - 0051	Seongnam-si
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution - 0053	Seoul
Korea, Republic of	Local Institution - 0055	Seoul
Korea, Republic of	Local Institution - 0305	Seoul
Korea, Republic of	Local Institution	Suwon
New Zealand	Local Institution	Mount Cook
New Zealand	Local Institution	Tauranga
Poland	ClinicMed Daniluk Nowak Spolka Jawna	Bialystok
Poland	Local Institution - 0104	Bialystok
Poland	ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik	Bialystok
Poland	Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska	Elblag
Poland	Local Institution - 0149	Gdansk
Poland	Synexus Polska Oddzial w Gdyni	Gdynia
Poland	Zespol Naukowo-Leczniczy Iwolang	Iwonicz-Zdroj
Poland	Synexus - Katowice	Katowice
Poland	Pratia MCM Krakow	Krak
Poland	Krakowskie Centrum Medyczne	Krakow
Poland	Centrum Medyczne All-Med	Lodz
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Local Institution - 0114	Lodz
Poland	Local Institution - 0144	Lodz
Poland	Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER	Lublin
Poland	Miejski Szpital Zespolony w Olsztynie	Olsztyn
Poland	DermoDent - Centrum Medyczne Czajkowscy	Osielsko
Poland	Local Institution - 0103	Poznan
Poland	Solumed Centrum Medyczne	Poznan
Poland	ETG - Siedlce	Siedlce
Poland	ETG - Skierniewice	Skierniewice
Poland	Local Institution - 0125	Torun
Poland	Local Institution - 0111	Warsaw
Poland	Clinical Research Group	Warszawa
Poland	ETG - Warszawa	Warszawa
Poland	High-Med Przychodnia Specjalistyczna	Warszawa
Poland	Local Institution - 0138	Warszawa	MZ
Poland	Local Institution - 0137	Wroc?aw
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	dermMedica Sp. z o.o.	Wroclaw
Poland	Local Institution - 0124	Wroclaw
Puerto Rico	Local Institution - 0289	San Juan
Russian Federation	Local Institution - 0178	Ekaterinburg
Russian Federation	Local Institution - 0172	Kazan
Russian Federation	Local Institution - 0187	Krasnodar
Russian Federation	Local Institution - 0169	Moscow
Russian Federation	Local Institution - 0171	Moscow
Russian Federation	Local Institution - 0175	Moscow
Russian Federation	Local Institution - 0190	Ryazan
Russian Federation	Local Institution - 0179	Saint Petersburg
Russian Federation	Local Institution - 0182	Saint Petersburg
Russian Federation	Local Institution - 0201	Saint Petersburg
Russian Federation	Local Institution - 0202	Saratov
Russian Federation	Local Institution - 0184	Smolensk
Russian Federation	Local Institution - 0222	Yaroslavl
Spain	Local Institution - 0223	Alcorcon
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Universitario Cruces	Barakaldo
Spain	Local Institution - 0225	Cordoba
Spain	Local Institution - 0226	Las Palmas De Gran Canaria
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Local Institution - 0227	Malaga
Spain	Hospital de Manises	Manises
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon
Sweden	Ladulaas Kliniska Studier	Boras
Sweden	ProbarE i Lund	Lund
Sweden	Local Institution - 0186	Solna
Taiwan	Local Institution - 0079	Kaohsiung
Taiwan	Local Institution - 0297	Kaohsiung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution - 0153	Taipei
Taiwan	Local Institution	Taipei City
United Kingdom	MAC Clinical Research - Cannock	Cannock
United Kingdom	Synexus - Lancashire Clinical Research Centre	Chorley
United Kingdom	Synexus - Manchester Clinical Research Centre	Chorley
United Kingdom	Synexus - Merseyside Clinical Research Centre	Chorley
United Kingdom	Mounts Bay Medical	Cornwall
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley
United Kingdom	MAC Clinical Research - Stockton	Durham
United Kingdom	MAC Clinical Research - Blackpool	Lancashire
United Kingdom	Burbage Surgery	Leicestershire
United Kingdom	Guys and Saint Thomas NHS Foundation Trust	London
United Kingdom	MAC Clinical Research - Manchester	Manchester
United Kingdom	Salford Royal NHS Foundation Trust	Manchester
United Kingdom	MAC Clinical Research - Liverpool	Prescot
United States	Radiant Research - Anderson	Anderson	South Carolina
United States	David Fivenson MD Dermatology	Ann Arbor	Michigan
United States	Local Institution - 0006	Arlington	Texas
United States	Bellaire Dermatology	Bellaire	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Local Institution - 0278	Birmingham	Alabama
United States	Total Skin and Beauty Dermatology Center	Birmingham	Alabama
United States	Local Institution - 0170	Boca Raton	Florida
United States	Local Institution - 0291	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	New England Research Associates	Bridgeport	Connecticut
United States	Montefiore Medical Center - Bronx	Bronx	New York
United States	PMG Research of Cary	Cary	North Carolina
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Ora	Chestnut Hill	Massachusetts
United States	ClinOhio Research Services	Columbus	Ohio
United States	Radiant Research - Columbus	Columbus	Ohio
United States	Local Institution - 0015	Dallas	Texas
United States	Local Institution - 0030	Dallas	Texas
United States	Local Institution - 0195	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	ERN - Accel Research Sites	DeLand	Florida
United States	Local Institution - 0016	East Windsor	New Jersey
United States	Clinical Research Advantage - Evansville - South Kenmore Drive	Evansville	Indiana
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Local Institution - 0045	Exton	Pennsylvania
United States	Local Institution - 0176	Fairborn	Ohio
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley	Fountain Valley	California
United States	Local Institution - 0206	Fresno	California
United States	Rivergate Dermatology - Main Office	Goodlettsville	Tennessee
United States	Local Institution - 0037	Greer	South Carolina
United States	Indago Research and Health Center	Hialeah	Florida
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center for Clinical Studies - Texas Medical Center	Houston	Texas
United States	Dawes Fretzin Dermatology Group	Indianapolis	Indiana
United States	Local Institution - 0017	Irvine	California
United States	Clinical Research Solutions - Jackson	Jackson	Tennessee
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Shondra L. Smith, M.D.	Lake Charles	Louisiana
United States	Clinical Research Consortium - Las Vegas	Las Vegas	Nevada
United States	Interspond - Long Beach Clinical Trials	Long Beach	California
United States	Dermatology Research Associates - Los Angeles	Los Angeles	California
United States	Local Institution - 0236	Los Angeles	California
United States	Local Institution - 0040	Louisville	Kentucky
United States	Local Institution - 0013	Marietta	Georgia
United States	Treasure Valley Dermatology & Skin Cancer Center	Meridian	Idaho
United States	Local Institution - 0234	Methuen	Massachusetts
United States	International Dermatology Research	Miami	Florida
United States	LCC Medical Research	Miami	Florida
United States	Local Institution - 0216	Miami	Florida
United States	Well Pharma Medical Research	Miami	Florida
United States	Interspond - Savin Medical Group	Miami Lakes	Florida
United States	Local Institution - 0007	Miami Lakes	Florida
United States	Clinical Trials of America - Monroe	Monroe	Louisiana
United States	Associated Skin Care Specialists - Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Local Institution - 0058	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	Coastal Carolina Research Center - Mount Pleasant	North Charleston	South Carolina
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Austin Institute for Clinical Research - Pflugerville	Pflugerville	Texas
United States	Alliance Dermatology and Mohs Center - Phoenix	Phoenix	Arizona
United States	Arizona Research Center	Phoenix	Arizona
United States	Local Institution - 0282	Pittsburgh	Pennsylvania
United States	Local Institution - 0020	Plainfield	Indiana
United States	Local Institution - 0198	Port Orange	Florida
United States	Local Institution - 0009	Portland	Oregon
United States	Local Institution - 0167	Portland	Oregon
United States	DermCare Experts	Quincy	Massachusetts
United States	Local Institution - 0004	Rapid City	South Dakota
United States	Northwest Arkansas Clinical Trials Center, PLLC	Rogers	Arkansas
United States	Washington University School of Medicine - West County Dermatology	Saint Louis	Missouri
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	University Dermatology Group	San Diego	California
United States	University of California San Diego Health Systems	San Diego	California
United States	Local Institution - 0094	San Luis Obispo	California
United States	Local Institution - 0235	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California
United States	NorthBay Clinical Research	Santa Rosa	California
United States	Synexus - Santa Rosa	Santa Rosa	California
United States	Local Institution - 0265	Seattle	Washington
United States	Local Institution - 0042	Sherman Oaks	California
United States	The South Bend Clinic	South Bend	Indiana
United States	Springfield Clinic	Springfield	Illinois
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Local Institution - 0218	Stony Brook	New York
United States	Interspond - Acclaim Dermatology	Sugar Land	Texas
United States	Interspond - Houston Center for Clinical Research	Sugar Land	Texas
United States	Local Institution - 0008	Tampa	Florida
United States	Local Institution - 0233	Tampa	Florida
United States	Local Institution - 0025	Troy	Michigan
United States	Synexus - Orange Grove Family Practice	Tucson	Arizona
United States	Care Access Research - Walnut Creek	Walnut Creek	California
United States	Center for Clinical Studies - Webster	Webster	Texas
United States	Dundee Dermatology	West Dundee	Illinois
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 244 weeks
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 244 weeks
Secondary	static Physician Global Assessment (sPGA) 0/1 response		Up to 240 weeks
Secondary	Psoriasis Area and Severity Index (PASI) 75 response		Up to 240 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls