Continuation Study of Zasocitinib for Psoriatic Arthritis
This study is looking at the long-term safety and effectiveness of zasocitinib, an oral tablet, for adults with psoriatic arthritis (PsA), a long-term inflammatory disease affecting joints and skin. You may be able to join this study if you have already completed a 52-week (1-year) treatment period in one of two previous zasocitinib studies (TAK-279-PsA-3001 or TAK-279-PsA-3002). All participants in this continuation study will receive zasocitinib once a day, at either a lower or higher dose. The study will monitor for any side effects, serious side effects, and other specific safety events, as well as changes in vital signs, over approximately 2 years (108 weeks).
- Study design
- This is an interventional study for adults who have completed a previous zasocitinib study. It plans to enroll 1182 participants.
- What's involved
- You would take zasocitinib oral tablets once a day for approximately 2 years (108 weeks).
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored from the start of study drug administration up to follow-up (up to Week 108).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
At a glance
Conditions
Where it's being run
45 sites across 24 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial 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 ValuesFrom 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 ValuesFrom 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.