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

NCT ID: NCT06671483
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 3
Sponsor: Takeda

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 1088 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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 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).

Study locations

185 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Belgium, Bulgaria, Chile, Croatia, Czechia, Estonia, Germany, Hungary, Israel, Italy, Latvia, Mexico, New Zealand, Poland, Portugal, Puerto Rico, South Korea, Spain, Taiwan, United States

Brussels Capital, Belgium: 1
Flanders, Belgium: 1
Limburg, Belgium: 1
Sofia-Grad, Bulgaria: 3
Santiago Metropolitan, Chile: 2
City of Zagreb, Croatia: 1
Czech Rep, Czechia: 5
Moravian-Silesian Region, Czechia: 1
NAP, Czechia: 1
Prague, Czechia: 1
Harju, Estonia: 2
Tartu, Estonia: 1
Lower Saxony, Germany: 1
Mecklenburg-Vorpommern, Germany: 1
North Rhine-Westphalia, Germany: 1
Saxony, Germany: 1
Csongrad-Csanad, Hungary: 2
Fejér, Hungary: 1
Southern District, Israel: 1
Ancona, Italy: 1
Lazio, Italy: 2
Lombardy, Italy: 2
Milano, Italy: 1
Veneto, Italy: 1
Estado de Baja California, Mexico: 1
Guadalajara, Mexico: 1
Jalisco, Mexico: 2
Mexico City, Mexico: 3
Yucatán, Mexico: 2
Christchurch, New Zealand: 1

Sample of listed locations

Université Libre de Bruxelles — Anderlecht, Brussels Capital, 1070, Belgium — Site recruitment status not specified in the registry data
University Hospital Ghent — Ghent, Flanders, 9000, Belgium — Site recruitment status not specified in the registry data
ReumaClinic Genk — Genk, Limburg, 3600, Belgium — Site recruitment status not specified in the registry data
St Pierre Brussels — Brussels, 1000, Belgium — Site recruitment status not specified in the registry data
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman — Liège, 4000, Belgium — Site recruitment status not specified in the registry data
Centre of Rheumatology St. Irina — Sofia, Sofia-Grad, 1784, Bulgaria — Site recruitment status not specified in the registry data
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD — Sofia, Sofia-Grad, 1463, Bulgaria — Site recruitment status not specified in the registry data
Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia — Sofia, Sofia-Grad, 1606, Bulgaria — Site recruitment status not specified in the registry data
Medical Center Medconsult Pleven OOD — Pleven, 5800, Bulgaria — Site recruitment status not specified in the registry data
AES Partner Site -Plovdiv — Plovdiv, 4000, Bulgaria — Site recruitment status not specified in the registry data
Medical Center Artmed OOD | Plovdiv, Bulgaria — Plovdiv, 4000, Bulgaria — Site recruitment status not specified in the registry data
Diagnostic- Consultative Center- 1- Ruse EOOD — Rousse, 7002, Bulgaria — Site recruitment status not specified in the registry data
Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria — Stara Zagora, 6000, Bulgaria — Site recruitment status not specified in the registry data
Medical Center Zara-Med EOOD — Stara Zagora, 6000, Bulgaria — Site recruitment status not specified in the registry data
El Centro de Estudios Reumatologicos (CER) — Providencia, Santiago Metropolitan, 7500000, Chile — Site recruitment status not specified in the registry data
Clinica Dermacross S.A. — Santiago, Santiago Metropolitan, 7640881, Chile — Site recruitment status not specified in the registry data
Centro de Estudios Clinicos — Santiago, 8320000, Chile — Site recruitment status not specified in the registry data
Centro Internacional de Estudios Clínicos — Santiago, 8420383, Chile — Site recruitment status not specified in the registry data
CTR Estudios — Santiago, 8320000, Chile — Site recruitment status not specified in the registry data
Medicinski Centar Kuna and Peric — Zagreb, City of Zagreb, 10000, Croatia — Site recruitment status not specified in the registry data
Clinical Hospital Centre Osijek — Osijek, 31000, Croatia — Site recruitment status not specified in the registry data
Clinical Hospital Center Rijeka — Rijeka, 51000, Croatia — Site recruitment status not specified in the registry data
University Hospital Centre Split — Split, 21000, Croatia — Site recruitment status not specified in the registry data
General Hospital Zadar — Zadar, 23000, Croatia — Site recruitment status not specified in the registry data
Revmatologie s.r.o. | Brno, Czech Republic — Brno, Czech Rep, 63800, Czechia — Site recruitment status not specified in the registry data

Study details

Start date: March 3, 2025
Primary completion date: May 18, 2027
First posted: November 4, 2024

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06671483
Registry last updated: September 17, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT06671483 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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