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ACTIVE NOT RECRUITING
NCT04036435
PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1466

Start Date

2019-08-12

Completion Date

2026-07-26

Last Updated

2025-10-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

BMS-986165

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Locations (302)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, United States

Local Institution - 0278

Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center - Phoenix

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Synexus - Orange Grove Family Practice

Tucson, Arizona, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, United States

Local Institution - 0046

Fountain Valley, California, United States

Local Institution - 0206

Fresno, California, United States

Local Institution - 0017

Irvine, California, 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

University of California San Diego Health Systems

San Diego, California, United States

Therapeutics Clinical Research

San Diego, California, United States

University Dermatology Group

San Diego, California, United States

Local Institution - 0094

San Luis Obispo, California, 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 - 0042

Sherman Oaks, California, United States

Care Access Research - Walnut Creek

Walnut Creek, California, United States

New England Research Associates

Bridgeport, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Local Institution - 0170

Boca Raton, Florida, United States

ERN - Accel Research Sites

DeLand, Florida, United States

Indago Research and Health Center

Hialeah, Florida, United States

LCC Medical Research

Miami, Florida, United States

International Dermatology Research

Miami, Florida, United States

Well Pharma Medical Research

Miami, Florida, United States

Local Institution - 0216

Miami, Florida, United States

Interspond - Savin Medical Group

Miami Lakes, Florida, United States

Local Institution - 0007

Miami Lakes, Florida, United States

Local Institution - 0198

Port Orange, Florida, United States

Local Institution - 0233

Tampa, Florida, United States

Local Institution - 0008

Tampa, Florida, United States

Local Institution - 0013

Marietta, Georgia, United States

Local Institution - 0235

Sandy Springs, Georgia, United States

Treasure Valley Dermatology & Skin Cancer Center

Meridian, Idaho, United States

Springfield Clinic

Springfield, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Deaconess Clinic Downtown

Evansville, Indiana, United States

Clinical Research Advantage - Evansville - South Kenmore Drive

Evansville, Indiana, United States

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, United States

Local Institution - 0020

Plainfield, Indiana, United States

The South Bend Clinic

South Bend, Indiana, United States

Local Institution - 0040

Louisville, Kentucky, United States

Shondra L. Smith, M.D.

Lake Charles, Louisiana, United States

Clinical Trials of America - Monroe

Monroe, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Local Institution - 0291

Boston, Massachusetts, United States

Ora

Chestnut Hill, Massachusetts, United States

Local Institution - 0234

Methuen, Massachusetts, United States

DermCare Experts

Quincy, Massachusetts, United States

David Fivenson MD Dermatology

Ann Arbor, Michigan, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Local Institution - 0025

Troy, Michigan, United States

Associated Skin Care Specialists - Minnesota Clinical Study Center

New Brighton, Minnesota, United States

Washington University School of Medicine - West County Dermatology

St Louis, Missouri, United States

Clinical Research Consortium - Las Vegas

Las Vegas, Nevada, United States

Hassman Research Institute

Berlin, New Jersey, United States

Local Institution - 0016

East Windsor, New Jersey, United States

Forest Hills Dermatology Group

Kew Gardens, New York, United States

Local Institution - 0058

New York, New York, United States

Local Institution - 0218

Stony Brook, New York, United States

Montefiore Medical Center - Bronx

The Bronx, New York, United States

PMG Research of Cary

Cary, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Radiant Research - Columbus

Columbus, Ohio, United States

ClinOhio Research Services

Columbus, Ohio, United States

Local Institution - 0176

Fairborn, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Local Institution - 0167

Portland, Oregon, United States

Local Institution - 0009

Portland, Oregon, United States

Local Institution - 0045

Exton, Pennsylvania, United States

Local Institution - 0282

Pittsburgh, Pennsylvania, United States

Radiant Research - Anderson

Anderson, South Carolina, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Local Institution - 0037

Greer, South Carolina, United States

Coastal Carolina Research Center - Mount Pleasant

North Charleston, South Carolina, United States

Local Institution - 0004

Rapid City, South Dakota, United States

Rivergate Dermatology - Main Office

Goodlettsville, Tennessee, United States

Clinical Research Solutions - Jackson

Jackson, Tennessee, United States

Dermatology Associates of Knoxville

Knoxville, Tennessee, United States

The Skin Wellness Center

Knoxville, Tennessee, United States

Local Institution - 0006

Arlington, Texas, United States

Bellaire Dermatology

Bellaire, Texas, United States

Local Institution - 0015

Dallas, Texas, United States

Local Institution - 0195

Dallas, Texas, United States

Local Institution - 0030

Dallas, Texas, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Center for Clinical Studies - Texas Medical Center

Houston, Texas, United States

Austin Institute for Clinical Research - Pflugerville

Pflugerville, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Interspond - Acclaim Dermatology

Sugar Land, Texas, United States

Interspond - Houston Center for Clinical Research

Sugar Land, Texas, United States

Center for Clinical Studies - Webster

Webster, Texas, United States

Local Institution - 0265

Seattle, Washington, United States

Woden Dermatology

Phillip, Australian Capital Territory, Australia

Local Institution - 0246

Darlinghurst, New South Wales, Australia

St. George Dermatology & Skin Care Centre

Kogarah, New South Wales, Australia

Local Institution - 0250

Westmead, New South Wales, Australia

The Skin Centre

Benowa, Queensland, Australia

Local Institution - 0241

Woolloongabba, Queensland, Australia

North Eastern Health Specialists

Hectorville, South Australia, Australia

Local Institution - 0245

Box Hill, Victoria, Australia

Skin and Cancer Foundation

Carlton, Victoria, Australia

Sinclair Dermatology

East Melbourne, Victoria, Australia

Local Institution - 0251

Parkville, Victoria, Australia

Local Institution - 0247

Perth, Western Australia, Australia

Beacon Dermatology

Calgary, Alberta, Canada

Stratica Medical

Edmonton, Alberta, Canada

SkinFit MD Laser and Cosmetic Clinic

Surrey, British Columbia, Canada

Local Institution - 0152

Vancouver, British Columbia, Canada

Wiseman Dermatology Research

Winnipeg, Manitoba, Canada

CCA Medical Research

Ajax, Ontario, Canada

Mediprobe Research

London, Ontario, Canada

Local Institution - 0090

London, Ontario, Canada

Lynderm Research

Markham, Ontario, Canada

DermEdge

Mississauga, Ontario, 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 - 0082

Richmond Hill, Ontario, Canada

Toronto Dermatology Centre

Toronto, Ontario, Canada

Local Institution - 0132

Toronto, Ontario, Canada

Kim Papp Clinical Research

Waterloo, Ontario, Canada

XLR8 Medical Research

Windsor, Ontario, Canada

Docteur David Gratton Dermatologue

Montreal, Quebec, Canada

Siena Medical Research

Montreal, Quebec, Canada

Local Institution - 0258

Québec, Quebec, Canada

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Chongqing, Chongqing Municipality, China

Local Institution

Wuhan, Hubei, China

Local Institution

Wuhan, Hubei, China

Local Institution - 0312

Nanjing, Jiangsu, China

Local Institution

Changchun, Jilin, China

Local Institution

Dalian, Liaoning, China

Local Institution

Taiyuan, Shan1xi, China

Local Institution - 0292

Shanghai, Shanghai Municipality, China

Local Institution

Chengdu, Sichuan, China

Local Institution

Hangzhou, Zhejiang, China

Local Institution

Hangzhou, Zhejiang, China

Local Institution

Hangzhou, Zhejiang, China

Local Institution

Hangzhou, Zhejiang, China

Nemocnice Jihlava

Jihlava, Czechia

Nemocnice Novy Jicin a.s.

Nový Jičín, Czechia

Local Institution - 0163

Olomouc, Czechia

Local Institution - 0165

Ostrava, Czechia

Clintrial

Prague, Czechia

Sanatorium profesora Arenbergera

Prague, Czechia

Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, Czechia

Local Institution - 0279

Tampere, Finland

Centre Hospitalier Universitaire de Nice Hopital lArchet

Nice, France

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, Germany

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

Nyíregyháza, Hungary

Local Institution - 0151

Pécs, Hungary

Allergo-Derm Bakos

Szolnok, Hungary

Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

Zalaegerszeg, Hungary

Local Institution - 0237

Haifa, Israel

Local Institution

Petah Tikva, Israel

Local Institution

Ramat Gan, Israel

Local Institution - 0065

Nagoya, Aichi-ken, Japan

Local Institution - 0069

Fukuoka, Fukuoka, Japan

Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Local Institution - 0075

Yokohama, Kanagawa, Japan

Local Institution - 0076

Nankoku, Kochi, Japan

Local Institution - 0066

Kyoto, Kyoto, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Local Institution - 0072

Matsumoto, Nagano, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Local Institution - 0061

Itabashi-Ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Local Institution - 0062

Shinagawa, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Japan Community Health Care Organization Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo, Japan

Local Institution - 0096

Kumamoto, Japan

Local Institution - 0093

Kyoto, Japan

Local Institution - 0073

Osaka, Japan

Local Institution - 0067

Osaka, Japan

Local Institution

Mount Cook, New Zealand

Local Institution

Tauranga, New Zealand

Local Institution - 0138

Warsaw, Masovian Voivodeship, 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

Local Institution - 0149

Gdansk, Poland

Synexus Polska Oddzial w Gdyni

Gdynia, Poland

Zespol Naukowo-Leczniczy Iwolang

Iwonicz-Zdrój, Poland

Synexus - Katowice

Katowice, Poland

Krakowskie Centrum Medyczne

Krakow, Poland

Pratia MCM Krakow

Krak, Poland

Centrum Terapii Wspolczesnej

Lodz, Poland

Local Institution - 0114

Lodz, Poland

Local Institution - 0144

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

Local Institution - 0103

Poznan, Poland

Solumed Centrum Medyczne

Poznan, Poland

ETG - Siedlce

Siedlce, Poland

Local Institution - 0113

Skierniewice, Poland

Local Institution - 0125

Torun, Poland

Clinical Research Group

Warsaw, Poland

High-Med Przychodnia Specjalistyczna

Warsaw, Poland

Local Institution - 0119

Warsaw, Poland

Local Institution - 0324

Warsaw, Poland

Local Institution - 0111

Warsaw, Poland

Local Institution - 0137

Wroc?aw, Poland

dermMedica Sp. z o.o.

Wroclaw, Poland

Local Institution - 0124

Wroclaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

Local Institution - 0289

San Juan, Puerto Rico

Local Institution - 0172

Kazan', Russia

Local Institution - 0187

Krasnodar, Russia

Local Institution - 0171

Moscow, Russia

Local Institution - 0175

Moscow, Russia

Local Institution - 0169

Moscow, Russia

Local Institution - 0190

Ryazan, Russia

Local Institution - 0179

Saint Petersburg, Russia

Local Institution - 0182

Saint Petersburg, Russia

Local Institution - 0201

Saint Petersburg, Russia

Local Institution - 0202

Saratov, Russia

Local Institution - 0184

Smolensk, Russia

Local Institution - 0222

Yaroslavl, Russia

Local Institution - 0178

Yekaterinburg, Russia

Local Institution - 0306

Seongnam-si, Gyeonggi-do, South Korea

Local Institution

Bucheon-si, South Korea

Local Institution - 0054

Busan, South Korea

Local Institution

Goyang-si, South Korea

Local Institution - 0310

Gwangju, South Korea

Local Institution

Hwaseong-si, South Korea

Local Institution

Incheon, South Korea

Local Institution

Incheon, South Korea

Local Institution - 0051

Seongnam-si, South Korea

Local Institution

Seoul, South Korea

Local Institution - 0305

Seoul, South Korea

Local Institution - 0055

Seoul, South Korea

Local Institution

Seoul, South Korea

Local Institution

Seoul, South Korea

Local Institution - 0053

Seoul, South Korea

Local Institution

Seoul, South Korea

Local Institution

Suwon, South Korea

Local Institution - 0223

Alcorcón, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Local Institution - 0230

Barakaldo, Spain

Local Institution - 0225

Córdoba, Spain

Local Institution - 0226

Las Palmas de Gran Canaria, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital de Manises

Manises, Spain

Local Institution - 0227

Málaga, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Spain

Ladulaas Kliniska Studier

Borås, Sweden

ProbarE i Lund

Lund, Sweden

Local Institution - 0186

Solna, Sweden

Local Institution - 0079

Kaohsiung City, Taiwan

Local Institution - 0297

Kaohsiung City, Taiwan

Local Institution

Taipei, Taiwan

Local Institution - 0153

Taipei, Taiwan

Local Institution

Taipei, Taiwan

Local Institution

Taipei, Taiwan

Local Institution

Taipei, Taiwan

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

Local Institution - 0212

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

Local Institution - 0209

Prescot, United Kingdom