A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

Study Purpose

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. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06671483
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Takeda
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Study Director
Principal Investigator Affiliation	Takeda
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Belgium, Bulgaria, Chile, Colombia, Croatia, Czechia, Estonia, Germany, Hungary, Israel, Italy, Latvia, Mexico, New Zealand, Poland, Portugal, Puerto Rico, South Korea, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Zasocitinib Dose A

Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.

Experimental: Zasocitinib Dose B

Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.

Active Comparator: Active Comparator Dose C

Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.

Experimental: Placebo + Zasoctinib

Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.

Interventions

Drug: - Zasocitinib

Zasocitinib over-encapsulated tablets.

Drug: - Active Comparator

Active comparator capsule.

Drug: - Placebo

Zasocitinib or active comparator matching placebo.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

AARR- Chandler AZ, Chandler 5289282, Arizona 5551752

Status

Recruiting

Address

AARR- Chandler AZ

Chandler 5289282, Arizona 5551752, 85225

Site Contact

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