A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
Launched by BRISTOL-MYERS SQUIBB · May 28, 2021
Trial Information
Current as of April 25, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called deucravacitinib to see how well it works and how safe it is for people with active psoriatic arthritis (PsA) who have not previously used biologic treatments. PsA is a type of arthritis that can cause joint pain and skin issues. The trial will compare the effects of deucravacitinib to a placebo, which is an inactive substance that looks like the medication but doesn’t actually contain any active ingredients. Participants will be monitored for their response to the treatment over time, and there will be a follow-up period to gather more information about the long-term effects of the medication.
To be eligible for this trial, participants need to have been diagnosed with psoriatic arthritis for at least three months and have active symptoms, including swollen and tender joints. They should also have a type of skin condition called plaque psoriasis. However, this trial is not open to individuals who have other autoimmune diseases, certain types of joint diseases, or who have previously used biologic therapies for PsA or psoriasis. Throughout the trial, participants can expect regular check-ups and assessments to track their health and the effectiveness of the treatment. It is important to note that this trial is currently active but not recruiting new participants.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
- • Meets the Classification Criteria for Psoriatic Arthritis at Screening.
- • Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
- • Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1.
- • Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
- • ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
- • Must have completed the week 52 treatment for the optional open-label long-term extension period.
- • Exclusion Criteria
- • Nonplaque psoriasis at screening or day 1.
- • Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
- • History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
- • Active fibromyalgia.
- • Received an approved or investigational biologic therapy for the treatment of PsA or PsO.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
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
Detroit, Michigan, United States
Westmead, New South Wales, Australia
Fountain Valley, California, United States
Southampton, , United Kingdom
Denver, Colorado, United States
Greenville, South Carolina, United States
Cordoba, , Argentina
Dublin, , Ireland
Galway, , Ireland
Clayton, Victoria, Australia
Yaroslavl, , Russian Federation
Perrysburg, Ohio, United States
Novosibirsk, , Russian Federation
Saratov, , Russian Federation
Middleburg Heights, Ohio, United States
Dallas, Texas, United States
Beckley, West Virginia, United States
Tainan, , Taiwan
Ryazan, , Russian Federation
Boise, Idaho, United States
Jackson, Tennessee, United States
Gainesville, Georgia, United States
Beckley, West Virginia, United States
Pavia, , Italy
Udine, , Italy
Kazan, , Russian Federation
Shenzhen, Guangdong, China
Guangzhou, Guangdong, China
Budapest, , Hungary
Corvallis, Oregon, United States
Budapest, , Hungary
Medellin, , Colombia
Novosibirsk, , Russian Federation
Hagerstown, Maryland, United States
Middleburg Heights, Ohio, United States
Kuopio, , Finland
Tainan, , Taiwan
Pardubice, , Czechia
Camberwell, Victoria, Australia
Juiz De Fora, Minas Gerais, Brazil
Juiz De Fora, Minas Gerais, Brazil
San Miguel De Tucuman, Tucuman, Argentina
Brasov, , Romania
Chihuahua, , Mexico
Denver, Colorado, United States
Rosario, Santa Fe, Argentina
Ostrava, , Czechia
Pardubice, , Czechia
Budapest, , Hungary
Hagerstown, Maryland, United States
Dalian, Liaoning, China
Woolloongabba, Queensland, Australia
Chelyabinsk, , Russian Federation
Mexico City, Distrito Federal, Mexico
Bialystok, , Poland
Olsztyn, , Poland
Guangzhou, Guangdong, China
Miami Lakes, Florida, United States
Swidnik, Lubelskie, Poland
Hefei, Anhui, China
Clearwater, Florida, United States
Veracruz, , Mexico
Krakow, , Poland
Stoke On Trent, , United Kingdom
Margate, Florida, United States
Chongqing, Chongqing, China
Sacramento, California, United States
Fullerton, California, United States
Kalispell, Montana, United States
Gdansk, Pomorskie, Poland
Poznan, Wielkopolskie, Poland
Czestochowa, śląskie, Poland
Plovdiv, , Bulgaria
Springfield, Missouri, United States
Merida, Yucatán, Mexico
Verona, , Italy
Phillip, Australian Capital Territory, Australia
Barranquilla, , Colombia
Schaumburg, Illinois, United States
Kemerovo, , Russian Federation
Salvador, Bahia, Brazil
Allen, Texas, United States
Warszawa, , Poland
Orland Park, Illinois, United States
Amarillo, Texas, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Cali, , Colombia
Bucharest, , Romania
Bucuresti, , Romania
Râmnicu Vâlcea, , Romania
Timisoara, , Romania
Barranquilla, , Colombia
Kazan, , Russian Federation
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
Jonesboro, Arkansas, United States
Los Angeles, California, United States
Palm Desert, California, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Toms River, New Jersey, United States
Voorhees, New Jersey, United States
Cleveland, Ohio, United States
Allen, Texas, United States
Córdoba, Cordoba, Argentina
Buenos Aires, Distrito Federal, Argentina
Dqg, Distrito Federal, Argentina
Capital, Mendoza, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Botany, New South Wales, Australia
Westmead, New South Wales, Australia
Woolloongabba, Queensland, Australia
Hobart, Tasmania, Australia
Camberwell, Victoria, Australia
Vitoria, Espirito Santo, Brazil
Sao Paulo, , Brazil
Santiago, Metropolitana, Chile
Santiago, Metropolitana, Chile
Santiago, Metropolitana, Chile
Hefei, Anhui, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Shenzhen, Guangdong, China
Dalian, Liaoning, China
Shanghai, Shanghai, China
Yiwu, Zhejiang, China
Bogota, , Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Medellín, , Colombia
Zipaquira, , Colombia
Ostrava, , Czechia
Prague, , Czechia
Praha 2, , Czechia
Helsinki, , Finland
Kuopio, , Finland
Turku, , Finland
Chambray Les Tours, , France
Montpellier, , France
Paris, , France
Székesfehérvár, Fejér, Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Zalaegerszeg, , Hungary
Manorhamilton, Leitrim, Ireland
Dublin, , Ireland
Genova, , Italy
Pavia, , Italy
Verona, , Italy
Saltillo, Coahuila, Mexico
Ciudad De México, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
San Luis Potosí, San Luis Potosi, Mexico
Mérida, Yucatan, Mexico
Chihuahua, , Mexico
Veracruz, , Mexico
Bialystok, , Poland
Krakow, , Poland
Kraków, , Poland
Olsztyn, , Poland
Poznan, , Poland
Poznan, , Poland
Warszawa, , Poland
Cluj Napoca, , Romania
Korolev, , Russian Federation
A Coruña, , Spain
Cordoba, , Spain
Madrid, , Spain
Sabadell, , Spain
Kaohsiung City, , Taiwan
Tainan, , Taiwan
Taipei City, , Taiwan
Taoyuan, , Taiwan
Harlow, , United Kingdom
Southampton, , United Kingdom
Stoke On Trent, , United Kingdom
Fontana, California, United States
Thousand Oaks, California, United States
Oklahoma City, Oklahoma, United States
Guangzhou, Guangdong, China
Bucaramanga, Santander, Colombia
Bogota, , Colombia
Medellin, , Colombia
Taipei City, , Taiwan
Bothell, Washington, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Skokie, Illinois, United States
Gilbert, Arizona, United States
Vitória, Espirito Santo, Brazil
Juiz De Fora, Minas Gerais, Brazil
Turku, , Finland
Warszawa, , Poland
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj Napoca, , Romania
Râmnicu Vâlcea, , Romania
Timisoara, , Romania
Warszawa, Mazowieckie, Poland
Caba, Ciudad Autónoma De Buenos Aires, Argentina
Quilmes, Ciudad Autónoma De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Santiago, Región Metropolitana De Santiago, Chile
Pardubice, , Czechia
Ciudad Autónoma De Buenos Aires, , Argentina
Phillip, Australian Capital Territory, Australia
Santiago, Región Metropolitana De Santiago, Chile
Praha, Praha 5, Czechia
Zlín, Zlínský Kraj, Czechia
Budapest, , Hungary
Dublin, , Ireland
Mexico City, Distrito Federal, Mexico
Warszawa, , Poland
Harlow, , United Kingdom
Porto Alegre, Rio Grande Do Sul, Brazil
Salvador, Bahia, Brazil
Bogotá, Cundinamarca, Colombia
Merida, Yucatán, Mexico
Lublin, Lubelskie, Poland
Swidnik, Lubelskie, Poland
Gmina Dąbrówka, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Wolomin, Mazowieckie, Poland
Plovdiv, , Bulgaria
Mendoza, , Argentina
Wroclaw, , Poland
Sofia, Sofia (Stolitsa), Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Nowy Targ, Małopolskie, Poland
Gdynia, Pomorskie, Poland
Poznan, Wielkopolskie, Poland
Czestochowa, śląskie, Poland
Manorhamilton, Leitrim, Ireland
Nadarzyn, Mazowieckie, Poland
Kraków, Małopolskie, Poland
Gdynia, Pomorskie, Poland
Plovdiv, , Bulgaria
Burgas, , Bulgaria
Chicago, Illinois, United States
Sofia, Sofia (Stolitsa), Bulgaria
Plovdiv, , Bulgaria
Kraków, , Poland
Wroclaw, , Poland
Southampton, Hampshire, United Kingdom
Santiago, Región Metropolitana De Santiago, Chile
Chambray Les Tours, , France
Guadalajara, Jalisco, Mexico
Lodz, łódzkie, Poland
Sofia, , Bulgaria
Wroclaw, Dolnośląskie, Poland
Warsaw, Mazowieckie, Poland
Krakow, Małopolskie, Poland
Gdansk, Pomorskie, Poland
Dąbrówka, Wielkopolskie, Poland
Lodz, łódzkie, Poland
Katowice, śląskie, Poland
Bucharest, București, Romania
Craiova, , Romania
Praha, Praha 5, Czechia
La Plata, Buenos Aires, Argentina
Montpellier, , France
Poznan, , Poland
Bucuresti, București, Romania
Iasi, Iași, Romania
Bucuresti, , Romania
Iași, , Romania
Tainan City, , Taiwan
Bucuresti, București, Romania
Iasi, Iași, Romania
Iași, , Romania
Katowice, śląskie, Poland
Plovdiv, , Bulgaria
Udine, , Italy
Buenos Aires, , Argentina
Viña Del Mar, Valparaíso, Chile
Paris, , France
Stoke On Trent, , United Kingdom
Salvador, Bahia, Brazil
Viña Del Mar, Valparaíso, Chile
Saltillo, Coahuila, Mexico
Mérida, Yucatán, Mexico
Warszawa, , Poland
Quilmes, Ciudad Autónoma De Buenos Aires, Argentina
Nadarzyn, Mazowieckie, Poland
Poznan, , Poland
Râmnicu Vâlcea, , Romania
Bucharest, București, Romania
Gdynia, Pomorskie, Poland
Barranquilla, Atlántico, Colombia
Santiago, Metropolitana, Chile
A Coruña, , Spain
Gilbert, Arizona, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Santiago, Metropolitana, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Bogotá, Cundinamarca, Colombia
Cali, , Colombia
Budapest, , Hungary
Galway, , Ireland
México, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Wroclaw, Dolnośląskie, Poland
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Kraków, Małopolskie, Poland
Dąbrówka, Wielkopolskie, Poland
Kraków, , Poland
Kraków, , Poland
Wroclaw, , Poland
Lodz, łódzkie, Poland
Bucharest, , Romania
Iași, , Romania
Timisoara, , Romania
Cordoba, , Spain
Cordoba, , Argentina
Vitória, Espirito Santo, Brazil
Plovdiv, , Bulgaria
Zipaquira, , Colombia
Uherske Hradiste, Zlínský Kraj, Czechia
Wołomin, Mazowieckie, Poland
Warszawa, , Poland
Sabadell, , Spain
Perrysburg, Ohio, United States
Greenville, South Carolina, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Bogota, , Colombia
Praha, , Czechia
Gyula, Békés, Hungary
Székesfehérvár, Fejér, Hungary
Genova, , Italy
San Luis Potosí, San Luis Potosi, Mexico
Yiwu, Zhejiang, China
Sacramento, California, United States
Chicago, Illinois, United States
Voorhees, New Jersey, United States
Dallas, Texas, United States
Botany, New South Wales, Australia
Curitiba, Paraná, Brazil
Beijing, Beijing, China
Shanghai, Shanghai, China
Bucaramanga, Santander, Colombia
Praha 2, , Czechia
Helsinki, , Finland
Turku, , Finland
Gyula, Békés, Hungary
Budapest, , Hungary
Poznan, , Poland
Brasov, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Iasi, , Romania
Madrid, , Spain
Kaohsiung City, , Taiwan
Taoyuan, , Taiwan
Harlow, , United Kingdom
Fontana, California, United States
Oklahoma City, Oklahoma, United States
Curitiba, Paraná, Brazil
Bucaramanga, Santander, Colombia
Manorhamilton, Leitrim, Ireland
Dublin, , Ireland
Dublin, , Ireland
Taipei City, , Taiwan
Gilbert, Arizona, United States
Jonesboro, Arkansas, United States
Fullerton, California, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Margate, Florida, United States
Miami Lakes, Florida, United States
Gainesville, Georgia, United States
Boise, Idaho, United States
Orland Park, Illinois, United States
Schaumburg, Illinois, United States
Hagerstown, Maryland, United States
Detroit, Michigan, United States
Springfield, Missouri, United States
Kalispell, Montana, United States
Voorhees, New Jersey, United States
Middleburg Heights, Ohio, United States
Corvallis, Oregon, United States
Jackson, Tennessee, United States
Allen, Texas, United States
Amarillo, Texas, United States
Bothell, Washington, United States
Beckley, West Virginia, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Caba, Ciudad Autónoma De Buenos Aires, Argentina
Córdoba, Cordoba, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mendoza, , Argentina
Santo Andre, São Paulo, Brazil
Sofia, , Bulgaria
Santiago, Región Metropolitana De Santiago, Chile
Yiwu, Zhejiang, China
Bucaramanga, Santander, Colombia
Cali, , Colombia
Uherske Hradiste, Zlínský Kraj, Czechia
Praha, , Czechia
Paris, , France
Budapest, , Hungary
Budapest, , Hungary
Galway, , Ireland
Saltillo, Coahuila, Mexico
México, Distrito Federal, Mexico
Mérida, Yucatán, Mexico
Warszawa, Mazowieckie, Poland
Wołomin, Mazowieckie, Poland
Gdynia, Pomorskie, Poland
Bucharest, București, Romania
Bucharest, , Romania
Iasi, , Romania
Iași, , Romania
Caba, Ciudad Autónoma De Buenos Aires, Argentina
Medellin, , Colombia
Lexington, Kentucky, United States
Oklahoma City, Oklahoma, United States
Quilmes, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Sofia, Sofia (Stolitsa), Bulgaria
Kuopio, Pohjois Savo, Finland
Mexico City, , Mexico
Râmnicu Vâlcea, Vâlcea, Romania
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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