Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT04036435 Active, not recruiting July 29, 2019 July 5, 2022

study description
Brief 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.

Condition or Disease: Psoriasis
Intervention/treatment: Drug: BMS-986165
Phase: Phase 3
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 1452 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
Actual Study Start Date: August 2019
Estimated Primary Completion Date: July 2026
Estimated Study Completion Date: July 2026

Arms and interventions
Arm Intervention/treatment
Experimental: BMS-986165
Drug: BMS-986165
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 244 weeks ]
2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 244 weeks ]
Secondary Outcome Measures: 1. static Physician Global Assessment (sPGA) 0/1 response [ Time Frame: Up to 240 weeks ]
2. Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: Up to 240 weeks ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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


Contacts and Locations
Contacts
Locations
United States, Alabama Total Skin and Beauty Dermatology Center Birmingham
United States, Alabama The Kirklin Clinic of UAB Hospital Birmingham
United States, Arizona Alliance Dermatology and Mohs Center - Phoenix Phoenix
United States, Arizona Arizona Research Center Phoenix
United States, Arizona Synexus - Orange Grove Family Practice Tucson
United States, Arkansas Johnson Dermatology Fort Smith
United States, Arkansas Burke Pharmaceutical Research Hot Springs
United States, Arkansas Northwest Arkansas Clinical Trials Center, PLLC Rogers
United States, California First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley Fountain Valley
United States, California Biomedic Skincare-Reena Simone Fresno
United States, California Local Institution - 0017 Irvine
United States, California Interspond - Long Beach Clinical Trials Long Beach
United States, California Dermatology Research Associates - Los Angeles Los Angeles
United States, California LA Universal Research Center Los Angeles
United States, California University of California San Diego Health Systems San Diego
United States, California Therapeutics Clinical Research San Diego
United States, California University Dermatology Group San Diego
United States, California San Luis Dermatology and Laser Clinic San Luis Obispo
United States, California Clinical Science Institute Santa Monica
United States, California NorthBay Clinical Research Santa Rosa
United States, California Synexus - Santa Rosa Santa Rosa
United States, California Unison Clinical Trials Sherman Oaks
United States, California Care Access Research - Walnut Creek Walnut Creek
United States, Connecticut New England Research Associates Bridgeport
United States, Connecticut Stamford Therapeutics Consortium Stamford
United States, Florida Skin Care Research Boca Raton
United States, Florida ERN - Accel Research Sites DeLand
United States, Florida Indago Research and Health Center Hialeah
United States, Florida Interspond - Savin Medical Group Miami Lakes
United States, Florida San Marcus Research Clinic Miami Lakes
United States, Florida LCC Medical Research Miami
United States, Florida International Dermatology Research Miami
United States, Florida Well Pharma Medical Research Miami
United States, Florida Local Institution - 0216 Miami
United States, Florida Progressive Medical Research Port Orange
United States, Florida Local Institution - 0233 Tampa
United States, Florida Olympian Clinical Research - Tampa Office Tampa
United States, Georgia Marietta Dermatology & The Skin Cancer Center Marietta
United States, Georgia Advanced Medical Research Sandy Springs
United States, Idaho Treasure Valley Dermatology & Skin Cancer Center Meridian
United States, Illinois Springfield Clinic Springfield
United States, Illinois Dundee Dermatology West Dundee
United States, Indiana Deaconess Clinic Downtown Evansville
United States, Indiana Clinical Research Advantage - Evansville - South Kenmore Drive Evansville
United States, Indiana Dawes Fretzin Dermatology Group Indianapolis
United States, Indiana The Indiana Clinical Trials Center Plainfield
United States, Indiana The South Bend Clinic South Bend
United States, Kentucky Skin Sciences Louisville
United States, Louisiana Shondra L. Smith, M.D. Lake Charles
United States, Louisiana Clinical Trials of America - Monroe Monroe
United States, Massachusetts Tufts Medical Center Boston
United States, Massachusetts Local Institution - 0291 Boston
United States, Massachusetts Ora Chestnut Hill
United States, Massachusetts ALLCUTIS Research Methuen
United States, Massachusetts DermCare Experts Quincy
United States, Michigan David Fivenson MD Dermatology Ann Arbor
United States, Michigan Hamzavi Dermatology Fort Gratiot
United States, Michigan Local Institution - 0025 Troy
United States, Minnesota Associated Skin Care Specialists - Minnesota Clinical Study Center New Brighton
United States, Missouri Washington University School of Medicine - West County Dermatology Saint Louis
United States, Nevada Clinical Research Consortium - Las Vegas Las Vegas
United States, New Jersey Hassman Research Institute Berlin
United States, New Jersey Psoriasis Treatment Center of Central New Jersey East Windsor
United States, New York Montefiore Medical Center - Bronx Bronx
United States, New York Forest Hills Dermatology Group Kew Gardens
United States, New York Mount Sinai West New York
United States, New York Local Institution - 0218 Stony Brook
United States, North Carolina PMG Research of Cary Cary
United States, North Carolina Wilmington Dermatology Center Wilmington
United States, Ohio Radiant Research - Columbus Columbus
United States, Ohio ClinOhio Research Services Columbus
United States, Ohio Wright State Research Institute Fairborn
United States, Oklahoma Central Sooner Research Norman
United States, Oklahoma Unity Clinical Research Oklahoma City
United States, Oregon Oregon Dermatology and Research Center Portland
United States, Oregon Local Institution - 0167 Portland
United States, Pennsylvania Dermatology and Skin Surgery Center - Exton Exton
United States, Pennsylvania University of Pittsburgh Medical Center Pittsburgh
United States, South Carolina Radiant Research - Anderson Anderson
United States, South Carolina Clinical Research Center of the Carolinas Charleston
United States, South Carolina Local Institution - 0037 Greer
United States, South Carolina Coastal Carolina Research Center - Mount Pleasant North Charleston
United States, South Dakota Health Concepts Rapid City
United States, Tennessee Rivergate Dermatology - Main Office Goodlettsville
United States, Tennessee Clinical Research Solutions - Jackson Jackson
United States, Tennessee Dermatology Associates of Knoxville Knoxville
United States, Tennessee The Skin Wellness Center Knoxville
United States, Texas Local Institution - 0006 Arlington
United States, Texas Bellaire Dermatology Bellaire
United States, Texas Dermatology Treatment and Research Center Dallas
United States, Texas Local Institution - 0195 Dallas
United States, Texas Radiant Research - Dallas Dallas
United States, Texas Menter Dermatology Research Institute Dallas
United States, Texas Center for Clinical Studies - Texas Medical Center Houston
United States, Texas Austin Institute for Clinical Research - Pflugerville Pflugerville
United States, Texas University of Texas Health Science Center at San Antonio San Antonio
United States, Texas Dermatology Clinical Research Center of San Antonio San Antonio
United States, Texas Interspond - Acclaim Dermatology Sugar Land
United States, Texas Interspond - Houston Center for Clinical Research Sugar Land
United States, Texas Center for Clinical Studies - Webster Webster
United States, Washington Dermatology Associates of Seattle Seattle
Australia, Australian Capital Territory Woden Dermatology Phillip
Australia, New South Wales Holdsworth House Medical Practice Darlinghurst
Australia, New South Wales St. George Dermatology & Skin Care Centre Kogarah
Australia, New South Wales Westmead Hospital Westmead
Australia, Queensland The Skin Centre Benowa
Australia, Queensland Veracity Clinical Research Woolloongabba
Australia, South Australia North Eastern Health Specialists Hectorville
Australia, Victoria Box Hill Hospital Box Hill
Australia, Victoria Skin and Cancer Foundation Carlton
Australia, Victoria Sinclair Dermatology East Melbourne
Australia, Victoria The Royal Melbourne Hospital Parkville
Australia, Western Australia Fremantle Dermatology Fremantle
Canada, Alberta Beacon Dermatology Calgary
Canada, Alberta Stratica Medical Edmonton
Canada, British Columbia SkinFit MD Laser and Cosmetic Clinic Surrey
Canada, British Columbia University of British Columbia Vancouver
Canada, Manitoba Wiseman Dermatology Research Winnipeg
Canada, Ontario CCA Medical Research Ajax
Canada, Ontario Mediprobe Research London
Canada, Ontario DermEffects London
Canada, Ontario Lynderm Research Markham
Canada, Ontario DermEdge Mississauga
Canada, Ontario North Bay Dermatology Centre North Bay
Canada, Ontario Office of Dr. Niakosari Firouzeh North York
Canada, Ontario Institute of Cosmetic and Laser Surgery Oakville
Canada, Ontario Skin Centre for Dermatology Peterborough
Canada, Ontario The Centre for Dermatology - Richmond Hill Richmond Hill
Canada, Ontario Toronto Dermatology Centre Toronto
Canada, Ontario Dermatology on Bloor Toronto
Canada, Ontario Kim Papp Clinical Research Waterloo
Canada, Ontario XLR8 Medical Research Windsor
Canada, Quebec Docteur David Gratton Dermatologue Montreal
Canada, Quebec Siena Medical Research Montreal
Canada Centre de Recherche Dermatologique du Quebec Metropolitain Quebec
China, Beijing Local Institution Beijing
China, Beijing Local Institution Beijing
China, Chongqing Local Institution Chongqing
China, Hubei Local Institution Wuhan
China, Hubei Local Institution Wuhan
China, Jiangsu Local Institution - 0312 Nanjing
China, Jilin Local Institution Changchun
China, Liaoning Local Institution Dalian
China, Shan1xi Local Institution Taiyuan
China, Shanghai Local Institution Shanghai
China, Sichuan Local Institution Chengdu
China, Zhejiang Local Institution Hangzhou
China, Zhejiang Local Institution Hangzhou
China, Zhejiang Local Institution Hangzhou
China, Zhejiang Local Institution Hangzhou
Czechia Nemocnice Jihlava Jihlava 1
Czechia Nemocnice Novy Jicin a.s. Novy Jicin
Czechia MUDr. Helena Korandova Olomouc
Czechia Fakultni Nemocnice Ostrava Ostrava
Czechia Clintrial Praha 10
Czechia Sanatorium profesora Arenbergera Praha 1
Czechia Krajska zdravotni - Masarykova nemocnice v Usti nad Labem Usti nad Labem
Finland Terveystalo Tampere 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 Synexus Magyarorszag Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site Debrecen
Hungary Debreceni Egyetem Klinikai Kozpont 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 Haifa
Israel Local Institution Petah Tikva
Israel Local Institution Ramat Gan
Japan, Aichi Nagoya City University Hospital Nagoya
Japan Local Institution - 0073 Osaka
Japan, Fukuoka Fukuoka University Hospital Fukuoka-shi
Japan, Hokkaido Sapporo Skin Clinic Sapporo
Japan, Hyogo Kobe University Hospital Kobe
Japan, Kanagawa Tokai University Hospital Isehara City
Japan, Kanagawa Local Institution - 0075 Yokohama-Shi
Japan, Kanagawa Yokohama City University Hospital Yokohama
Japan, Kochi Local Institution - 0076 Nankoku
Japan, Kyoto University Hospital - Kyoto Preferctural University of Medicine Kyoto-city
Japan, Kyoto Kyoto University Hospital Kyoto-City
Japan, MIE Mie University Hospital Tsu
Japan, Nagano Shinshu University Hospital Matsumoto
Japan, Okayama Kurashiki Central Hospital Kurashiki
Japan, Shizuoka Hamamatsu University Hospital Hamamatsu
Japan, Tochigi Jichi Medical University Hospital Shimotsuke
Japan, Tokyo Teikyo University Hospital Itabashi-Ku
Japan, Tokyo Nihon University Itabashi Hospital Itabashi-ku
Japan, Tokyo The Jikei University Hospital Minato-ku
Japan, Tokyo NTT Medical Center Tokyo Shinagawa
Japan, Tokyo Tokyo Medical University Hospital Shinjuku-ku
Japan, Tokyo Japan Community Health Care Organization Tokyo Yamate Medical Center Shinjuku-ku
Japan Kumamoto University Hospital Kumamoto
Japan Nippon Life Hospital Osaka
Korea, Republic of Local Institution Bucheon-si
Korea, Republic of Local Institution 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 Seongnam-si
Korea, Republic of Local Institution Seoul
Korea, Republic of Local Institution - 0305 Seoul
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 Seoul
Korea, Republic of Local Institution Suwon
New Zealand Local Institution Mount Cook
New Zealand Local Institution Tauranga
Poland Local Institution - 0104 Bialystok
Poland ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik Bialystok
Poland ClinicMed Daniluk Nowak Spolka Jawna Bialystok
Poland Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska Elblag
Poland Synexus Polska Oddzial w Gdansk Gda?sk
Poland Synexus Polska Oddzial w Gdyni Gdynia
Poland Zespol Naukowo-Leczniczy Iwolang Iwonicz-Zdroj
Poland Synexus - Katowice Katowice
Poland Krakowskie Centrum Medyczne Krakow
Poland Pratia MCM Krakow Krak
Poland Centrum Terapii Wspolczesnej Lodz
Poland Dermed Centrum Medyczne Lodz
Poland Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak Lodz
Poland Centrum Medyczne All-Med Lodz
Poland Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER Lublin
Poland Miejski Szpital Zespolony w Olsztynie Olsztyn
Poland DermoDent - Centrum Medyczne Czajkowscy Osielsko
Poland Solumed Centrum Medyczne Poznan
Poland Local Institution - 0103 Poznan
Poland ETG - Siedlce Siedlce
Poland ETG - Skierniewice Skierniewice
Poland Local Institution - 0125 Torun
Poland Klinika Ambroziak Warsaw
Poland Clinical Research Group Warszawa
Poland High-Med Przychodnia Specjalistyczna Warszawa
Poland ETG - Warszawa Warszawa
Poland Royalderm Agnieszka Nawrocka Warszawa
Poland Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska Wroc?aw
Poland dermMedica Sp. z o.o. Wroclaw
Poland WroMedica Wroclaw
Poland Centrum Medyczne Oporow Wroclaw
Puerto Rico GCM Medical Group San Juan
Russian Federation Ural Scientific Research Institute of Dermatovenereology and Immunopathology Ekaterinburg
Russian Federation Azbuka Zdorovya Medical Center Kazan
Russian Federation SBHI Clinical Skin and Venereology Dispensary of the Ministry of Health of Krasnodar Region Krasnodar
Russian Federation NIARMEDIK - Clinic on Clinic on Kitai Gorod Moscow
Russian Federation Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov Moscow
Russian Federation Ars Vitae Multidisciplinary Medical Center Moscow
Russian Federation State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary Ryazan
Russian Federation Clinic of Skin Diseases of Pierre Wolkenstein Saint Petersburg
Russian Federation Polyclinic of Private Security Personnel Saint Petersburg
Russian Federation Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology Saint Petersburg
Russian Federation Klinika Kozhnykh I Venericheskikh Bolezney Saratov
Russian Federation Smolensk State Medical University Smolensk
Russian Federation MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev 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 Hospital Universitario de Gran Canaria Doctor Negrin Las Palmas De Gran Canaria
Spain Hospital Universitario Ramon Y Cajal Madrid
Spain Hospital de Manises Manises
Spain Hospital Universitario Virgen de la Victoria Mߧa
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 Kaohsiung
Taiwan Local Institution - 0297 Kaohsiung
Taiwan Local Institution Taipei City
Taiwan Local Institution Taipei
Taiwan Local Institution - 0153 Taipei
Taiwan Local Institution Taipei
Taiwan Local Institution Taipei
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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT04036435     
Other Study ID Numbers : IM011-075, 2019-000612-29
First Posted : July 29, 2019
Last Update Posted : July 5, 2022
Last Verified : July 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: Psoriasis
Additional relevant MeSH terms :
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases