Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Zasocitinib: Zasocitinib oral tablets.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (78)

+ 38 more sites — see the full list on the official registry below.

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