Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Launched by BRISTOL-MYERS SQUIBB · Aug 4, 2025
Trial Information
Current as of September 11, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the long-term safety of two medicines, Deucravacitinib and Ustekinumab, in people with moderate-to-severe plaque psoriasis, a common skin condition that causes red, scaly patches. The goal is to see how these treatments compare over time, especially in people who also have certain heart-related risk factors like smoking, high blood pressure, diabetes, or a family history of heart disease.
To join the study, participants need to have moderate-to-severe plaque psoriasis and be considered suitable for treatment like phototherapy or systemic medicines, including Ustekinumab. They also must have at least one heart-related risk factor. People who recently had serious heart problems, unstable heart conditions, or recent cancer are not eligible. Participants can expect regular check-ups to monitor their health and how they respond to the treatment. The study is not recruiting yet, but it aims to help doctors understand which medicine might be safer for people with psoriasis and heart risks over the long term.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Participants with moderate-to-severe plaque psoriasis:
- • 1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- 2. Have at least 1 of the following cardiovascular risk factors:
- • Current cigarette smoker
- • Diagnosis of hypertension
- • Diagnosis of hyperlipidemia
- • Diabetes mellitus type 1 or 2
- • History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
- • Obesity
- • Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.
- Exclusion Criteria:
- • Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.
- • Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.
- • Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
- • Other protocol define inclusion/exclusion criteria apply.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Palmdale, California, United States
Pasadena, California, United States
Pomona, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
Santa Clarita, California, United States
Walnut Creek, California, United States
Washington, District Of Columbia, United States
Coral Gables, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Bowling Green, Kentucky, United States
Owensboro, Kentucky, United States
Covington, Louisiana, United States
New Orleans, Louisiana, United States
Milford, Massachusetts, United States
Quincy, Massachusetts, United States
Clinton Township, Michigan, United States
Columbia, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
North Las Vegas, Nevada, United States
Portsmouth, New Hampshire, United States
Teaneck, New Jersey, United States
Kew Gardens, New York, United States
New City, New York, United States
New York, New York, United States
New York, New York, United States
Cary, North Carolina, United States
Chapel Hill, North Carolina, United States
Chapel Hill, North Carolina, United States
Hickory, North Carolina, United States
Canal Winchester, Ohio, United States
Medina, Ohio, United States
Medford, Oregon, United States
Camp Hill, Pennsylvania, United States
Exton, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
North Charleston, South Carolina, United States
Rapid City, South Dakota, United States
Goodlettsville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Buenos Aires, Caba, Argentina
Ciudad Autonoma Buenos Aires, C, Argentina
Ciudad Autónoma De Buenos Aires, C, Argentina
Autonomous City Of Buenos Aires, Argentina
Cordoba, Argentina
Mendoza, Argentina
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Westmead, New South Wales, Australia
Woolloongabba, Queensland, Australia
Woolloongabba, Queensland, Australia
Clayton, Victoria, Australia
East Melbourne, Victoria, Australia
Woluwe Saint Lambert, Bru, Belgium
Gent, Vov, Belgium
Juiz De Fora, Mg, Brazil
João Pessoa, Pb, Brazil
Curitiba, Pr, Brazil
Curitiba, Pr, Brazil
Porto Alegre, Rs, Brazil
Porto Alegre, Rs, Brazil
Botucatu, Sp, Brazil
São José Do Rio Preto, Sp, Brazil
Campinas, Brazil
Ribeirão Preto, Brazil
Sao Paulo, Brazil
São Paulo, Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Nanaimo, British Columbia, Canada
Surrey, British Columbia, Canada
St. John's, Newfoundland And Labrador, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Ottawa, Ontario, Canada
Québec, Quebec, Canada
Santiago De Chile, Metropolitana, Chile
Santiago, Metropolitana, Chile
Santiago, Metropolitana, Chile
Viña Del Mar, Chile
Bengbu, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Fuzhou, Fj, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Shijiazhuang, Hebei, China
Harbin Shi, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Zhenjiang, Jiangsu, China
Changchun, Jilin, China
Shenyan, Liaoning, China
Taiyuan, China
Jinan Shi, Shandong, China
Jinan, Shandong, China
Chengdu Shi, Sichuan Provience, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Changsha Shi, China
Hangzhou, China
Nanjing, China
Shenzhen, China
Praha, Pr, Czechia
Brno, Czechia
Olomouc, Czechia
Prague, Czechia
Usti Nad Labem, Czechia
Copenhagen, Capital Region, Denmark
Herlev, Rh, Denmark
Aarhus, Denmark
Hellerup, Denmark
Nantes, France
Rennes, France
Berlin, Be, Germany
Mahlow, Brandenburg, Germany
Freiburg Im Breisgau, Bw, Germany
Heidelberg, Bw, Germany
Langenau, Bw, Germany
Tuebingen, Bw, Germany
Memmingen, By, Germany
Frankfurt Am Main, He, Germany
Bramsche, Lower Saxony, Germany
Mainz, Rp, Germany
Quedlinburg, Saint, Germany
Dresden, Saxonia, Germany
Leipzig, Sn, Germany
Szeged, Csongrad, Hungary
Budapest, Hungary
Debrecen, Hungary
Veszprem, Hungary
L'aquila, Aq, Italy
Modena, Mo, Italy
Bologna, Italy
Naples, Italy
Roma, Italy
Toyoake Shi, Aichi, Japan
Suita Shi, Osaka, Japan
Suita, Osaka, Japan
Otsu, Shiga, Japan
Gifu Shi, Japan
Itabashi Ku, Japan
Kanazawa, Japan
Kurume, Fukuoka, Japan
Okayama, Japan
Sakai Shi, Japan
Sakai Shi, Japan
Seongnam Si, Gyeonggi Do, Gyeonggi Do, Korea, Republic Of
Seoul, Korea, Republic Of
Mexicali, Baja California, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Monterrey, Nle, Mexico
Monterrey, Nuevo Leon, Mexico
Merida, Yuc, Mexico
Chihuahua, Mexico
Mexico City, Mexico
Torun, Kp, Poland
Pulawy, Lubelskie, Poland
Warsaw, Mazowieckie, Poland
Rzeszow, Podkarpackie, Poland
Bialystok, Podlaskie, Poland
Katowice, Slaskie, Poland
Kielce, Swietokrzyskie, Poland
Olsztyn, Warmia Masuria, Poland
Poznan, Wielkopolska, Poland
Bialystok, Poland
Gdansk, Poland
Gdynia, Poland
Katowice, Poland
Katowice, Poland
Lodz, Poland
Mikolow, Poland
Skierniewice, Poland
Wroclaw, Poland
Craiova, Dolj, Romania
Iasi, Is, Romania
Reghin, Ms, Romania
Timisoara, Timis, Romania
Brasov, Romania
Bucharest, Romania
Bucharest, Romania
Constanta, Romania
Iași, Romania
Las Palmas De Gran Canaria, Las Palmas, Spain
Alcorcón, Madrid, Spain
Sevilla, Se, Spain
Boras, Sweden
Zuoying Dist, Kaohsiung, Taiwan
Taipei, Taiwan
High Wycombe, Bucks, United Kingdom
Dunfermline, Fif, United Kingdom
London, Greater London, United Kingdom
Southampton, Hampshire, United Kingdom
London, Lnd, United Kingdom
Salford, Slf, United Kingdom
Fayetteville, Arkansas, United States
Cary, North Carolina, United States
Bexley, Ohio, United States
Carlton, Victoria, Australia
Calgary, Alberta, Canada
Montréal, Quebec, Canada
Praha, Czechia
Nice, France
Friedrichshafen, Baden Wuerttemberg, Germany
Erlangen, By, Germany
Witten, Northwest, Germany
Mainz, Rhineland Palatinate, Germany
Kiel, Sh, Germany
Berlin, Germany
Halle, Germany
Hamburg, Germany
Asahikawa Shi, Hokkaido, Japan
Caguas, Puerto Rico
Iași, Is, Romania
London, On, United Kingdom
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported