A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Launched by TAKEDA · Oct 31, 2024
Trial Information
Current as of May 06, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called zasocitinib (also known as TAK-279) to see how well it works for adults with psoriatic arthritis (PsA) who have not previously received biologic treatments. PsA is a long-term condition that causes joint pain and skin problems in people who also have psoriasis. The trial will involve participants taking either zasocitinib, an active comparison medicine, or a placebo (a treatment that looks like the real medicine but has no active ingredients) over a period of up to 60 weeks.
To be eligible for this trial, participants need to be at least 18 years old (or 19 in South Korea) and have experienced symptoms of PsA for at least three months. They should also have active arthritis and at least one skin issue related to psoriasis. Importantly, participants must have not had a good response to other common treatments for PsA. Throughout the study, participants will be closely monitored to assess the effectiveness of the medication and any side effects. This trial is currently recruiting individuals of all genders who meet the criteria, and it aims to provide valuable information about new treatment options for PsA.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Age:
- • 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age.
- Disease Characteristics:
- • 2. The participant has had signs and symptoms consistent with PsA for at least 3 months.
- • 3. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
- • 4. The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
- • 5. The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
- Medications for PsA:
- 6. The participant has had at least one of the following:
- • 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
- • 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
- Exclusion Criteria:
- PsA and PsO:
- • 1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
- • 2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
Dallas, Texas, United States
Sarasota, Florida, United States
Sevilla, , Spain
Seoul, , Korea, Republic Of
Tamarac, Florida, United States
Marietta, Georgia, United States
Jackson, Tennessee, United States
Bad Bentheim, Niedersachsen, Germany
Pisa, , Italy
Split, , Croatia
Firenze, , Italy
La Mesa, California, United States
Taichung, , Taiwan
Rijeka, , Croatia
Hagerstown, Maryland, United States
Middleburg Heights, Ohio, United States
Malaga, , Spain
Tel Aviv, , Israel
Haifa, , Israel
Houston, Texas, United States
Rozzano, Milano, Italy
Chia, Cundinamarca, Colombia
Pleven, , Bulgaria
Osijek, , Croatia
Roma, Lazio, Italy
Dresden, , Germany
Almada, , Portugal
Zadar, , Croatia
Plano, Texas, United States
Seoul, , Korea, Republic Of
Leipzig, Sachsen, Germany
Baytown, Texas, United States
Krakow, Malopolskie, Poland
Lisboa, , Portugal
Seoul, , Korea, Republic Of
Saint Clair Shores, Michigan, United States
Tainan City, , Taiwan
Liege, , Belgium
Kraków, Malopolskie, Poland
Lubbock, Texas, United States
Saint Louis, Missouri, United States
Northridge, California, United States
Gustavo A. Madero, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Krakow, Malopolskie, Poland
Warszawa, Mazowieckie, Poland
Coral Gables, Florida, United States
Warszawa, Mazowieckie, Poland
Ashdod, Hadarom, Israel
Fountain Valley, California, United States
Tallinn, Harjumaa, Estonia
Sofia, Sofia Grad, Bulgaria
Wrocław, , Poland
Stara Zagora, , Bulgaria
Hickory, North Carolina, United States
Katowice, Dolnoslaskie, Poland
Santiago, , Chile
Hialeah, Florida, United States
Phoenix, Arizona, United States
Plantation, Florida, United States
Cleveland, Ohio, United States
Hamburg, , Germany
Chandler, Arizona, United States
La Mesa, California, United States
Mather, California, United States
Poway, California, United States
Thousand Oaks, California, United States
Tujunga, California, United States
Whittier, California, United States
Denver, Colorado, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Cooper City, Florida, United States
Davie, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Tampa, Florida, United States
Orland Park, Illinois, United States
Schaumburg, Illinois, United States
Lake Charles, Louisiana, United States
Detroit, Michigan, United States
Grand Blanc, Michigan, United States
Lansing, Michigan, United States
Saline, Michigan, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Brooklyn, New York, United States
Wyomissing, Pennsylvania, United States
Houston, Texas, United States
Houston, Texas, United States
Mesquite, Texas, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Anderlecht, Brussels, Belgium
Gent, Flanders, Belgium
Genk, Limburg, Belgium
Brussels, , Belgium
Sofia, Sofia Grad, Bulgaria
Sofia, Sofia Grad, Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Stara Zagora, , Bulgaria
Santiago, Region Metropolitana De Santiago, Chile
Providencia, Santiago, Chile
Santiago, , Chile
Santiago, , Chile
Barranquilla, Atlantico, Colombia
Bogota D.C., Cundinamarca, Colombia
Bogotá D.C., Cundinamarca, Colombia
Bucaramanga, Cundinamarca, Colombia
Zagreb, Grad Zagreb, Croatia
Brno, Czech Rep, Czechia
Hlučín, Czech Rep, Czechia
Prague, Czech Rep, Czechia
Praha 10, Czech Rep, Czechia
Uherske Hradiste, Czech Rep, Czechia
Ostrava, Moravskoslezský Kraj, Czechia
Zlin, Nap, Czechia
Praha 2, Prague, Czechia
Pardubice, , Czechia
Tallinn, Harjumaa, Estonia
Tartu, Tartumaa, Estonia
Tallinn, , Estonia
Tartu, , Estonia
Bad Doberan, Mv, Germany
Ratingen, North Rhine Westphalia, Germany
Berlin, , Germany
Hamburg, , Germany
München, , Germany
Hodmezovasarhely, Csongrad Csanad, Hungary
Szeged, Csongrad Csanad, Hungary
Szekesfehervar, Fejer, Hungary
Budapest, , Hungary
Szekesfehervar, , Hungary
Veszprem, , Hungary
Ashkelon, , Israel
Nahariya, , Israel
Ramat Gan, , Israel
Torrette, Ancona, Italy
Roma, Lazio, Italy
Milan, Lombardia, Italy
Milan, Lombardia, Italy
Padova, Padua, Italy
Suwon Si, Gyeonggi Do, Korea, Republic Of
Suwon Si, Gyeonggido, Korea, Republic Of
Liepaja, , Latvia
Riga, , Latvia
Mexicali, Baja California, Mexico
Ciudad De Mexico, Cdmx, Mexico
Zapopan, Guadalajara, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Merida, Yucatan, Mexico
Merida, Yucatan, Mexico
Chihuahua, , Mexico
Christchurch Central, Christchurch, New Zealand
Auckland, North Island, New Zealand
Auckland, North Island, New Zealand
Nelson, South Island, New Zealand
Hamilton, Waikato, New Zealand
Wroclaw, Dolnoslaskie, Poland
Sochaczew, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Opole, Opolskie, Poland
Bialystok, Podlaskie, Poland
Bialystok, Podlaskie, Poland
Bialystok, Podlaskie, Poland
Torun, Silesia, Poland
Olsztyn, Warmia Masuria, Poland
Dabrowka, Warmian Masurian Voivodeship, Poland
Elbląg, Warminsko Mazurskie, Poland
Poznan, Wielkopolska, Poland
Poznan, Wlkp, Poland
Poznan, Woj. Wielkopolskie, Poland
Poznan, Wojewodztwo Wielkopolskie, Poland
Nowa Sól, , Poland
łódź, , Poland
łódź, , Poland
Bytom, śląskie, Poland
Coimbra, Barcelona, Portugal
Ponte De Lima, Barcelona, Portugal
Vila Nova De Gaia, New Mexico, Portugal
Lisboa, , Portugal
Caguas, , Puerto Rico
San Juan, , Puerto Rico
Merida, Badajoz, Spain
Sabadell, Barcelona, Spain
Santiago De Compostela, Galicia, Spain
Tainan, Tainan City, Taiwan
Zhong Zheng Qu, Taipei City, Taiwan
New Taipei City, , Taiwan
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported