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New treatment option for Psoriatic Arthritis
Official title A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
ClinicalTrials.gov ID: NCT06671483
What this study is testing
What is Zasocitinib?
Zasocitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for psoriatic arthritis.
Also referred to as TAK- 279, NDI-034858.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.
- Phase 3: a large, late-stage study
- Time commitment: about 60 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age:
- 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...
- The participant has a diagnosis of PsA.
- The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
- The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
You likely can't join if
- PsA and PsO:
- The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid...
- The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such...
See the full eligibility criteria
- Age:
- 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:
- The participant has a diagnosis of PsA.
- The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
- The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
- 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.
- 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:
- The participant has had at least one of the following:
- Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union [EU]/ European Economic Area [EEA]), OR
- Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
- PsA and PsO:
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Fountain Valley, California, United States
- La Mesa, 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
- Coral Gables, Florida, United States
- Davie, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Ormond Beach, Florida, United States
- Plantation, Florida, United States
- Sarasota, Florida, United States
+ 136 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 60 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Fountain Valley, California, United States; La Mesa, California, United States; Thousand Oaks, California, United States; Tujunga, California, United States and 150 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.