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

Takeda

Status and phase: Enrolling; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Active Comparator; Drug: Zasocitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06671483

TAK-279-PsA-3001

2024-513111-27-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 1,088 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,088 participants in 4 patient groups

Zasocitinib Dose A

Experimental group

Description:

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

Treatment:

Drug: Zasocitinib

Zasocitinib Dose B

Experimental group

Description:

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

Treatment:

Drug: Zasocitinib

Active Comparator Dose C

Active Comparator group

Description:

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

Treatment:

Drug: Active Comparator

Placebo + Zasoctinib

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zasocitinib