Testing Zasocitinib for Psoriatic Arthritis in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of zasocitinib (TAK-279) in adults with active psoriatic arthritis (PsA) who have not previously received biologic treatments. Participants will be randomly assigned to receive either zasocitinib, an active comparator, or a placebo for up to 60 weeks. The study aims to assess improvements in joint and skin symptoms associated with PsA. Inclusion criteria include having active arthritis and meeting specific classification criteria for PsA.

Why it matters

Who can join: the full rules

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 a diagnosis of PsA.
3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
5. 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.
6. 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:
7. The participant has had at least one of the following:

   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), 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).

Where it's running

• AARR- Chandler AZ
  Chandler, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
  Phoenix, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
  Phoenix, Arizona, United States Recruiting
• First OC Dermatology Research Inc.
  Fountain Valley, California, United States Recruiting
• Purushotham & Akther Kotha MD
  La Mesa, California, United States Recruiting
• Triwest Research Associates LLC
  La Mesa, California, United States Recruiting

+138 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Picankibart for people with active psoriatic arthritis

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  Recruiting Phase 2/3 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Hangzhou, Zhejiang · NCT07295509

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.