MedPath

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

Phase 3
Active, not recruiting
Conditions
Psoriasis
Interventions
Registration Number
NCT04036435
Lead Sponsor
Bristol-Myers Squibb
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1452
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
Read More
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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
BMS-986165BMS-986165-
Primary Outcome Measures
NameTimeMethod
Incidence of Adverse Events (AEs)Up to 244 weeks
Incidence of Serious Adverse Events (SAEs)Up to 244 weeks
Secondary Outcome Measures
NameTimeMethod
Psoriasis Area and Severity Index (PASI) 75 responseUp to 240 weeks
static Physician Global Assessment (sPGA) 0/1 responseUp to 240 weeks

Trial Locations

Locations (270)

First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley

🇺🇸

Fountain Valley, California, United States

Local Institution - 0007

🇺🇸

Miami Lakes, Florida, United States

Radiant Research - Anderson

🇺🇸

Anderson, South Carolina, United States

Local Institution - 0015

🇺🇸

Dallas, Texas, United States

Menter Dermatology Research Institute

🇺🇸

Dallas, Texas, United States

Interspond - Houston Center for Clinical Research

🇺🇸

Sugar Land, Texas, United States

Local Institution - 0051

🇰🇷

Seongnam-si, Korea, Republic of

Local Institution - 0149

🇵🇱

Gdansk, Poland

Krakowskie Centrum Medyczne

🇵🇱

Krakow, Poland

Solumed Centrum Medyczne

🇵🇱

Poznan, Poland

Local Institution - 0184

🇷🇺

Smolensk, Russian Federation

Hospital Universitario Cruces

🇪🇸

Barakaldo, Spain

Local Institution - 0227

🇪🇸

Malaga, Spain

Synexus - Lancashire Clinical Research Centre

🇬🇧

Chorley, United Kingdom

MAC Clinical Research - Blackpool

🇬🇧

Lancashire, United Kingdom

Radiant Research - Columbus

🇺🇸

Columbus, Ohio, United States

Local Institution - 0282

🇺🇸

Pittsburgh, Pennsylvania, United States

Tufts Medical Center

🇺🇸

Boston, Massachusetts, United States

Local Institution - 0291

🇺🇸

Boston, Massachusetts, United States

Center for Clinical Studies - Texas Medical Center

🇺🇸

Houston, Texas, United States

International Dermatology Research

🇺🇸

Miami, Florida, United States

Well Pharma Medical Research

🇺🇸

Miami, Florida, United States

Local Institution - 0216

🇺🇸

Miami, Florida, United States

Dawes Fretzin Dermatology Group

🇺🇸

Indianapolis, Indiana, United States

University of California San Diego Health Systems

🇺🇸

San Diego, California, United States

University Dermatology Group

🇺🇸

San Diego, California, United States

Dermatology Clinical Research Center of San Antonio

🇺🇸

San Antonio, Texas, United States

Associated Skin Care Specialists - Minnesota Clinical Study Center

🇺🇸

New Brighton, Minnesota, United States

Local Institution - 0247

🇦🇺

Perth, Western Australia, Australia

Alliance Dermatology and Mohs Center - Phoenix

🇺🇸

Phoenix, Arizona, United States

Arizona Research Center

🇺🇸

Phoenix, Arizona, United States

Clinical Trials of America - Monroe

🇺🇸

Monroe, Louisiana, United States

University of British Columbia

🇨🇦

Vancouver, British Columbia, Canada

Central Sooner Research

🇺🇸

Norman, Oklahoma, United States

XLR8 Medical Research

🇨🇦

Windsor, Ontario, Canada

Clinical Research Solutions - Jackson

🇺🇸

Jackson, Tennessee, United States

The Skin Centre

🇦🇺

Benowa, Queensland, Australia

Skin and Cancer Foundation

🇦🇺

Carlton, Victoria, Australia

Synexus Magyarorszag

🇭🇺

Budapest, Hungary

Interspond - Savin Medical Group

🇺🇸

Miami Lakes, Florida, United States

Indago Research and Health Center

🇺🇸

Hialeah, Florida, United States

Johnson Dermatology

🇺🇸

Fort Smith, Arkansas, United States

New England Research Associates

🇺🇸

Bridgeport, Connecticut, United States

Debreceni Egyetem Klinikai Kozpont

🇭🇺

Debrecen, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

🇭🇺

Pecs, Hungary

Local Institution - 0237

🇮🇱

Haifa, Israel

Local Institution - 0067

🇯🇵

Osaka, Japan

Local Institution - 0305

🇰🇷

Seoul, Korea, Republic of

Local Institution - 0245

🇦🇺

Box Hill, Victoria, Australia

Local Institution - 0090

🇨🇦

London, Ontario, Canada

Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula

🇭🇺

Gyula, Hungary

Kobe University Hospital

🇯🇵

Kobe, Hyogo, Japan

Jichi Medical University Hospital

🇯🇵

Shimotsuke, Tochigi, Japan

Local Institution - 0104

🇵🇱

Bialystok, Poland

Local Institution - 0234

🇺🇸

Methuen, Massachusetts, United States

Northwest Arkansas Clinical Trials Center, PLLC

🇺🇸

Rogers, Arkansas, United States

Semmelweis Egyetem

🇭🇺

Budapest, Hungary

Clinical Research Consortium - Las Vegas

🇺🇸

Las Vegas, Nevada, United States

Local Institution - 0037

🇺🇸

Greer, South Carolina, United States

Tokai University Hospital

🇯🇵

Isehara City, Kanagawa, Japan

Local Institution - 0062

🇯🇵

Shinagawa, Tokyo, Japan

Local Institution - 0054

🇰🇷

Busan, Korea, Republic of

ClinicMed Daniluk Nowak Spolka Jawna

🇵🇱

Bialystok, Poland

High-Med Przychodnia Specjalistyczna

🇵🇱

Warszawa, Poland

Rivergate Dermatology - Main Office

🇺🇸

Goodlettsville, Tennessee, United States

Coastal Carolina Research Center - Mount Pleasant

🇺🇸

North Charleston, South Carolina, United States

Lynderm Research

🇨🇦

Markham, Ontario, Canada

Local Institution - 0258

🇨🇦

Quebec, Canada

Praxis Dr. med. Wilfried Steinborn

🇩🇪

Straubing, Germany

Allergo-Derm Bakos

🇭🇺

Szolnok, Hungary

Local Institution - 0076

🇯🇵

Nankoku, Kochi, Japan

Kurashiki Central Hospital

🇯🇵

Kurashiki, Okayama, Japan

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

🇵🇱

Elblag, Poland

Pratia MCM Krakow

🇵🇱

Krak, Poland

Japan Community Health Care Organization Tokyo Yamate Medical Center

🇯🇵

Shinjuku-ku, Tokyo, Japan

Teikyo University Hospital

🇯🇵

Itabashi-Ku, Tokyo, Japan

Nihon University Itabashi Hospital

🇯🇵

Itabashi-ku, Tokyo, Japan

Local Institution - 0292

🇨🇳

Shanghai, Shanghai, China

Tokyo Medical University Hospital

🇯🇵

Shinjuku-ku, Tokyo, Japan

The Jikei University Hospital

🇯🇵

Minato-ku, Tokyo, Japan

ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

🇵🇱

Bialystok, Poland

Local Institution - 0125

🇵🇱

Torun, Poland

Local Institution - 0222

🇷🇺

Yaroslavl, Russian Federation

Local Institution - 0111

🇵🇱

Warsaw, Poland

ETG - Warszawa

🇵🇱

Warszawa, Poland

Centrum Medyczne Oporow

🇵🇱

Wroclaw, Poland

Local Institution - 0187

🇷🇺

Krasnodar, Russian Federation

Local Institution - 0169

🇷🇺

Moscow, Russian Federation

Local Institution - 0289

🇵🇷

San Juan, Puerto Rico

Local Institution - 0182

🇷🇺

Saint Petersburg, Russian Federation

Sinclair Dermatology

🇦🇺

East Melbourne, Victoria, Australia

Synexus - Orange Grove Family Practice

🇺🇸

Tucson, Arizona, United States

Wiseman Dermatology Research

🇨🇦

Winnipeg, Manitoba, Canada

Local Institution - 0170

🇺🇸

Boca Raton, Florida, United States

Burke Pharmaceutical Research

🇺🇸

Hot Springs, Arkansas, United States

Local Institution - 0206

🇺🇸

Fresno, California, United States

Interspond - Long Beach Clinical Trials

🇺🇸

Long Beach, California, United States

Local Institution - 0236

🇺🇸

Los Angeles, California, United States

Dermatology Research Associates - Los Angeles

🇺🇸

Los Angeles, California, United States

Therapeutics Clinical Research

🇺🇸

San Diego, California, United States

NorthBay Clinical Research

🇺🇸

Santa Rosa, California, United States

Clinical Science Institute

🇺🇸

Santa Monica, California, United States

Local Institution - 0094

🇺🇸

San Luis Obispo, 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

ERN - Accel Research Sites

🇺🇸

DeLand, Florida, United States

Stamford Therapeutics Consortium

🇺🇸

Stamford, Connecticut, United States

LCC Medical Research

🇺🇸

Miami, Florida, United States

Local Institution - 0198

🇺🇸

Port Orange, Florida, United States

Local Institution - 0013

🇺🇸

Marietta, Georgia, United States

Local Institution - 0235

🇺🇸

Sandy Springs, Georgia, United States

Dundee Dermatology

🇺🇸

West Dundee, Illinois, United States

Springfield Clinic

🇺🇸

Springfield, Illinois, United States

Deaconess Clinic Downtown

🇺🇸

Evansville, Indiana, United States

Local Institution - 0020

🇺🇸

Plainfield, Indiana, United States

Clinical Research Advantage - Evansville - South Kenmore Drive

🇺🇸

Evansville, Indiana, United States

The South Bend Clinic

🇺🇸

South Bend, Indiana, United States

Shondra L. Smith, M.D.

🇺🇸

Lake Charles, Louisiana, United States

DermCare Experts

🇺🇸

Quincy, Massachusetts, United States

Local Institution - 0025

🇺🇸

Troy, Michigan, United States

Hamzavi Dermatology

🇺🇸

Fort Gratiot, Michigan, United States

Washington University School of Medicine - West County Dermatology

🇺🇸

Saint Louis, Missouri, United States

Hassman Research Institute

🇺🇸

Berlin, New Jersey, United States

Local Institution - 0016

🇺🇸

East Windsor, New Jersey, United States

Local Institution - 0058

🇺🇸

New York, New York, United States

Forest Hills Dermatology Group

🇺🇸

Kew Gardens, New York, United States

Local Institution - 0218

🇺🇸

Stony Brook, New York, United States

PMG Research of Cary

🇺🇸

Cary, North Carolina, United States

ClinOhio Research Services

🇺🇸

Columbus, Ohio, United States

Local Institution - 0176

🇺🇸

Fairborn, Ohio, United States

Wilmington Dermatology Center

🇺🇸

Wilmington, North Carolina, United States

Local Institution - 0045

🇺🇸

Exton, Pennsylvania, United States

Local Institution - 0004

🇺🇸

Rapid City, South Dakota, United States

Bellaire Dermatology

🇺🇸

Bellaire, Texas, United States

Local Institution - 0195

🇺🇸

Dallas, Texas, United States

Local Institution - 0006

🇺🇸

Arlington, Texas, United States

Local Institution - 0030

🇺🇸

Dallas, Texas, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

Austin Institute for Clinical Research - Pflugerville

🇺🇸

Pflugerville, Texas, United States

Center for Clinical Studies - Webster

🇺🇸

Webster, Texas, United States

Interspond - Acclaim Dermatology

🇺🇸

Sugar Land, Texas, United States

Woden Dermatology

🇦🇺

Phillip, Australian Capital Territory, Australia

Local Institution - 0265

🇺🇸

Seattle, Washington, United States

St. George Dermatology & Skin Care Centre

🇦🇺

Kogarah, New South Wales, Australia

Holdsworth House Medical Practice

🇦🇺

Darlinghurst, New South Wales, Australia

Local Institution - 0250

🇦🇺

Westmead, New South Wales, Australia

North Eastern Health Specialists

🇦🇺

Hectorville, South Australia, Australia

Veracity Clinical Research

🇦🇺

Woolloongabba, Queensland, Australia

Local Institution - 0251

🇦🇺

Parkville, Victoria, Australia

Beacon Dermatology

🇨🇦

Calgary, Alberta, Canada

Stratica Medical

🇨🇦

Edmonton, Alberta, Canada

CCA Medical Research

🇨🇦

Ajax, Ontario, Canada

SkinFit MD Laser and Cosmetic Clinic

🇨🇦

Surrey, British Columbia, Canada

Mediprobe Research

🇨🇦

London, Ontario, Canada

DermEdge

🇨🇦

Mississauga, Ontario, Canada

North Bay Dermatology Centre

🇨🇦

North Bay, Ontario, Canada

Local Institution - 0088

🇨🇦

Peterborough, Ontario, Canada

Office of Dr. Niakosari Firouzeh

🇨🇦

North York, Ontario, Canada

Institute of Cosmetic and Laser Surgery

🇨🇦

Oakville, Ontario, Canada

Local Institution - 0082

🇨🇦

Richmond Hill, Ontario, Canada

Local Institution - 0132

🇨🇦

Toronto, Ontario, Canada

Toronto Dermatology Centre

🇨🇦

Toronto, Ontario, Canada

Kim Papp Clinical Research

🇨🇦

Waterloo, Ontario, Canada

Docteur David Gratton Dermatologue

🇨🇦

Montreal, Quebec, Canada

Siena Medical Research

🇨🇦

Montreal, Quebec, Canada

Local Institution

🇨🇳

Taipei, Taiwan

Nemocnice Jihlava

🇨🇿

Jihlava 1, Czechia

Local Institution - 0312

🇨🇳

Nanjing, Jiangsu, China

Nemocnice Novy Jicin a.s.

🇨🇿

Novy Jicin, Czechia

Local Institution - 0279

🇫🇮

Tampere, Finland

Sanatorium profesora Arenbergera

🇨🇿

Praha 1, Czechia

MUDr. Helena Korandova

🇨🇿

Olomouc, Czechia

Fakultni Nemocnice Ostrava

🇨🇿

Ostrava, Czechia

Clintrial

🇨🇿

Praha 10, Czechia

Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

🇨🇿

Usti nad Labem, Czechia

Centre Hospitalier Universitaire de Nice Hopital lArchet

🇫🇷

Nice cedex 3, France

Licca Clinical Research Institute

🇩🇪

Augsburg, 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

Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

🇩🇪

Bochum, Germany

CentroDerm Privatklinik

🇩🇪

Wuppertal, Germany

Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

🇭🇺

Budapest, Hungary

Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

🇭🇺

Debrecen, Hungary

Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

🇭🇺

Nyiregyhaza, Hungary

Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

🇭🇺

Zalaegerszeg, Hungary

Local Institution - 0065

🇯🇵

Nagoya, Aichi, Japan

Fukuoka University Hospital

🇯🇵

Fukuoka-shi, Fukuoka, Japan

Sapporo Skin Clinic

🇯🇵

Sapporo, Hokkaido, Japan

Local Institution - 0075

🇯🇵

Yokohama-Shi, Kanagawa, Japan

Yokohama City University Hospital

🇯🇵

Yokohama, Kanagawa, Japan

Kyoto University Hospital

🇯🇵

Kyoto-City, Kyoto, Japan

Local Institution - 0066

🇯🇵

Kyoto-city, Kyoto, Japan

Mie University Hospital

🇯🇵

Tsu, MIE, Japan

Local Institution - 0072

🇯🇵

Matsumoto, Nagano, Japan

Hamamatsu University Hospital

🇯🇵

Hamamatsu, Shizuoka, Japan

Kumamoto University Hospital

🇯🇵

Kumamoto, Japan

Local Institution - 0073

🇯🇵

Osaka, Japan

Local Institution - 0310

🇰🇷

Gwangju, Korea, Republic of

Local Institution - 0053

🇰🇷

Seoul, Korea, Republic of

Local Institution - 0138

🇵🇱

Warszawa, MZ, Poland

Synexus Polska Oddzial w Gdyni

🇵🇱

Gdynia, Poland

Zespol Naukowo-Leczniczy Iwolang

🇵🇱

Iwonicz-Zdroj, Poland

Synexus - Katowice

🇵🇱

Katowice, Poland

Centrum Terapii Wspolczesnej

🇵🇱

Lodz, Poland

Local Institution - 0144

🇵🇱

Lodz, Poland

Centrum Medyczne All-Med

🇵🇱

Lodz, Poland

Local Institution - 0114

🇵🇱

Lodz, Poland

Miejski Szpital Zespolony w Olsztynie

🇵🇱

Olsztyn, Poland

Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

🇵🇱

Lublin, Poland

DermoDent - Centrum Medyczne Czajkowscy

🇵🇱

Osielsko, Poland

Local Institution - 0103

🇵🇱

Poznan, Poland

ETG - Siedlce

🇵🇱

Siedlce, Poland

ETG - Skierniewice

🇵🇱

Skierniewice, Poland

Clinical Research Group

🇵🇱

Warszawa, Poland

dermMedica Sp. z o.o.

🇵🇱

Wroclaw, Poland

Local Institution - 0178

🇷🇺

Ekaterinburg, Russian Federation

Local Institution - 0137

🇵🇱

Wroc?aw, Poland

Local Institution - 0124

🇵🇱

Wroclaw, Poland

Local Institution - 0172

🇷🇺

Kazan, Russian Federation

Local Institution - 0171

🇷🇺

Moscow, Russian Federation

Local Institution - 0175

🇷🇺

Moscow, Russian Federation

Local Institution - 0201

🇷🇺

Saint Petersburg, Russian Federation

Local Institution - 0190

🇷🇺

Ryazan, Russian Federation

Local Institution - 0179

🇷🇺

Saint Petersburg, Russian Federation

Local Institution - 0202

🇷🇺

Saratov, Russian Federation

Local Institution - 0223

🇪🇸

Alcorcon, Spain

Hospital Universitari Germans Trias i Pujol

🇪🇸

Badalona, Spain

Local Institution - 0225

🇪🇸

Cordoba, Spain

Local Institution - 0226

🇪🇸

Las Palmas De Gran Canaria, Spain

ProbarE i Lund

🇸🇪

Lund, Sweden

Hospital de Manises

🇪🇸

Manises, Spain

Hospital Universitario Quironsalud Madrid

🇪🇸

Pozuelo de Alarcon, Spain

Ladulaas Kliniska Studier

🇸🇪

Boras, Sweden

Local Institution - 0186

🇸🇪

Solna, Sweden

Local Institution - 0153

🇨🇳

Taipei, Taiwan

Local Institution - 0079

🇨🇳

Kaohsiung, Taiwan

Local Institution - 0297

🇨🇳

Kaohsiung, Taiwan

MAC Clinical Research - Cannock

🇬🇧

Cannock, United Kingdom

Synexus - Manchester Clinical Research Centre

🇬🇧

Chorley, United Kingdom

Burbage Surgery

🇬🇧

Leicestershire, United Kingdom

Synexus - Merseyside Clinical Research Centre

🇬🇧

Chorley, United Kingdom

Mounts Bay Medical

🇬🇧

Cornwall, United Kingdom

MAC Clinical Research - Stockton

🇬🇧

Durham, United Kingdom

Salford Royal NHS Foundation Trust

🇬🇧

Manchester, United Kingdom

The Dudley Group NHS Foundation Trust

🇬🇧

Dudley, United Kingdom

Guys and Saint Thomas NHS Foundation Trust

🇬🇧

London, United Kingdom

MAC Clinical Research - Manchester

🇬🇧

Manchester, United Kingdom

MAC Clinical Research - Liverpool

🇬🇧

Prescot, United Kingdom

Total Skin and Beauty Dermatology Center

🇺🇸

Birmingham, Alabama, United States

Local Institution - 0278

🇺🇸

Birmingham, Alabama, United States

Local Institution - 0233

🇺🇸

Tampa, Florida, United States

Local Institution - 0008

🇺🇸

Tampa, Florida, United States

Local Institution - 0040

🇺🇸

Louisville, Kentucky, United States

David Fivenson MD Dermatology

🇺🇸

Ann Arbor, Michigan, United States

Unity Clinical Research

🇺🇸

Oklahoma City, Oklahoma, United States

Local Institution - 0009

🇺🇸

Portland, Oregon, United States

Local Institution - 0167

🇺🇸

Portland, Oregon, United States

Clinical Research Center of the Carolinas

🇺🇸

Charleston, South Carolina, United States

Ora

🇺🇸

Chestnut Hill, Massachusetts, United States

Local Institution - 0017

🇺🇸

Irvine, California, United States

Dermatology Associates of Knoxville

🇺🇸

Knoxville, Tennessee, United States

The Skin Wellness Center

🇺🇸

Knoxville, Tennessee, United States

Local Institution - 0055

🇰🇷

Seoul, Korea, Republic of

Hospital Universitario Ramon Y Cajal

🇪🇸

Madrid, Spain

Montefiore Medical Center - Bronx

🇺🇸

Bronx, New York, United States

Treasure Valley Dermatology & Skin Cancer Center

🇺🇸

Meridian, Idaho, United States

© Copyright 2025. All Rights Reserved by MedPath