Brief Summary

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.

The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.

Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).

Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

Conditions

• Psoriatic Arthritis

Intervention / Treatment

• Drug: Zasocitinib

Primary Outcome Measures

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From start of study drug administration up to follow-up (up to Week 108))
  An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any AE emerging or manifesting at or after the initiation of treatment in the LTE study with a trial intervention or medicinal product or any existing AE that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.
• Number of Participants With Adverse Events of Special Interest (AESI) (From start of study drug administration up to follow-up (up to Week 108))
  An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
• Number of Participants With Clinically Significant Changes in Vital Sign Values (From start of study drug administration up to follow-up (up to Week 108))
  Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
• Number of Participants With Clinically Significant Changes in Clinical Laboratory Values (From start of study drug administration up to follow-up (up to Week 108))
  Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.

Countries

Australia, China, Croatia, Czechia, Estonia, Germany, Hungary, Israel, Japan, Latvia, New Zealand, Poland, Puerto Rico, Spain, Taiwan, United States

Locations and Investigators

• Multi Profile Hospital For Active Treatment Trimontium OOD, Plovdiv, Bulgaria
  • Ivan, Yakov
• Medical Center Artmed Ltd., Plovdiv, Bulgaria
  • Mariela, Geneva-Popova
• Military Medical Academy, Sofiya, Bulgaria
  • Boycho, Oparanov
• Dkc Fokus-5 Lzip OOD, Sofiya, Bulgaria
  • Rasho, Rashkov
• Medical Center Medconsult Pleven OOD, Pleven, Bulgaria
  • Krasimira, Tsoneva
• Medical Center Zara-Med EOOD, Stara Zagora, Bulgaria
  • Hristo, Vasilev
• Opca Bolnica Zadar, Zadar, Croatia
  • Kristina, Frketić Marović
• KBC Split, Split, Croatia
  • Mislav, Radic
• Medicinski centar Kuna Peric d.o.o., Grad Zagreb, Croatia
  • Porin, Perić
• Klinički bolnički centar Rijeka, Rijeka, Croatia
  • Srđan, Novak
• Klinicki Bolnicki Centar Osijek, Osijek, Croatia
  • Jasminka, Milas-Ahić
• Center for Clinical and Basic Research AS, Tallinn, Estonia
  • Ivo, Valter
• MediTrials OÜ, Tartu Linn, Estonia
  • Raili, Müller
• Kliiniliste Uuringute Keskus OÜ, Tartu Linn, Estonia
  • Airi, Pöder
• North Estonia Medical Centre Foundation, Tallinn, Estonia
  • Eve-Kai, Raussi
• Innomedica OÜ, Tallinn, Estonia
  • Sandra, Meisalu
• Centre Hospitalier Universitaire De Saint Etienne, Saint Priest En Jarez, France
  • Hubert, MAROTTE
• Centre Hospitalier Universitaire Reims, Reims Cedex, France
  • Jean-Hugues, SALMON
• Centre Hospitalier Regional Universitaire De Tours, Chambray Les Tours, France
  • Philippe, GOUPILLE
• Centre Hospitalier Universitaire De Toulouse, Toulouse, France
  • Arnaud, CONSTANTIN
• ISA Interdisciplinary Study Association GmbH, Berlin, Germany
  • Margrit, Simon
• Universitaetsklinikum Leipzig AöR, Leipzig, Germany
  • Ulf, Wagner
• Medicover GmbH, Munich, Germany
  • David, Kofler
• Rheumatologische Schwerpunktpraxis, Berlin, Germany
  • Jan, Brandt-Juergens
• MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH, Hamburg, Germany
  • Andrea, Everding
• St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr, Herne, Germany
  • Ioana, Andreica
• Prof. Dr. med. Gunther Neeck MVZ GmbH, Bad Doberan, Germany
  • Gunther, Neeck
• Staedtisches Klinikum Dresden, Dresden, Germany
  • Olaf, Nestler
• Studienambulanz Rheumazentrum Ratingen GbR, Ratingen, Germany
  • Siegfried, Wassenberg
• Thermalsole und Schwefelbad Bentheim GmbH, Bad Bentheim, Germany
  • Athanasios, Tsianakas
• Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto, Milan, Italy
  • Ennio Giulio, Favalli
• Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
  • Marta, Mosca
• Azienda Ospedaliero Universitaria Careggi, Florence, Italy
  • Serena, Guiducci
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
  • Maria Antonietta, D'Agostino
• Ospedale San Raffaele S.r.l., Milan, Italy
  • Lorenzo, Dagna
• Humanitas Mirasole S.p.A., Rozzano, Italy
  • Carlo Francesco, Selmi
• Azienda Ospedaliera di Padova, Padova, Italy
  • Roberta, Ramonda
• Azienda Ospedaliero Universitaria Delle Marche, Ancona, Italy
  • Michele Maria, Luchetti Gentiloni
• Azienda Ospedaliera Policlinico Universitario Tor Vergata, Rome, Italy
  • Maria Sole, Chimenti
• Dr. Saulite-Kandevica Private Practice, Liepaja, Latvia
  • Daina, Saulite-Kandevica
• Orto klinika SIA, Riga, Latvia
  • Anna, Mihailova
• Unidade Local De Saude De Coimbra E.P.E., Coimbra, Portugal
  • Mary, Marques
• Unidade Local De Saude De Almada-Seixal E.P.E., Almada, Portugal
  • Maria, Santos
• Instituto Portugues De Reumatologia, Lisbon, Portugal
  • Helena, Santos
• Unidade Local De Saude De Santa Maria E.P.E., Lisbon, Portugal
  • Elsa, Sousa
• Unidade Local De Saude De Gaia/Espinho E.P.E., Vila Nova De Gaia, Portugal
  • Flavio, Costa
• Unidade Local De Saude Do Alto Minho E.P.E., Ponte De Lima, Portugal
  • Jose, Costa
• Zdrowie Osteo Medic sc L. i A. Racewicz, A. i J. Supronik, Białystok, Poland
  • Artur, Racewicz
• Rcmed Oddzial Sochaczew, Sochaczew, Poland
  • Monika, Wronisz
• Pratia S.A., Gdynia, Poland
  • Anna, Sylwestrzak

And 66 other sites.

Study Officials

• Study Director (Study Director) — Takeda