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

RecruitingPhase 3

A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)

Who can join

Ages 18 and older · All sexes

Full 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).

About the study

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.

What is being tested

Sponsor: Takeda · Participants: 1,088 · Started: Mar 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06671483

Locations in the U.S.

ArizonaAARR- Chandler AZ, Chandler
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ, Phoenix
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ, Phoenix
CaliforniaFirst OC Dermatology Research Inc., Fountain Valley
Purushotham & Akther Kotha MD, La Mesa
Triwest Research Associates LLC, La Mesa
The Cohen Medical Centers, Thousand Oaks
Foothill Arthritis Clinic, Tujunga
ColoradoDenver Arthritis Clinic | Denver, CO, Denver
FloridaArthritis & Rheumatic Disease Specialties (AARDS), Aventura
RASF- Clinical Research Center, Boca Raton
Clinical Research of West Florida | Clearwater, FL, Clearwater
GNP Research, LLC | Hollywood, FL, Cooper City
Tectum Medical Research, Davie
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research, Hialeah
Bioresearch Partners, Miami
Millennium Research | Ormond Beach, FL, Ormond Beach
IRIS Research and Development | Plantation, FL, Plantation
Sarasota Arthritis Research Center, Sarasota
West Broward Rheumatology Associates, Inc., Tamarac
Clinical Research of West Florida | Tampa, FL, Tampa
GeorgiaMarietta Rheumatology Associates, Marietta
IllinoisGSCP/CIS, Orland Park
Greater Chicago Specialty Physicians LLC/CIS, Schaumburg
LouisianaAccurate Clinical Research, Inc. | Lake Charles, Lake Charles
MarylandKlein & Associates, M.D., P.A., Hagerstown
MichiganMichigan Rheumatology Group, P.C. - Grand Blanc Office, Grand Blanc
Ash Research Clinic - Howell, Howell
June DO, PC Private Practice - Dr. Justus Fiechtner, Lansing
Clinical Research Institute of Michigan, Saint Clair Shores
MissouriSaint Louis Rheumatology, St Louis
New MexicoAlbuquerque Center for Rheumatology PC, Albuquerque
Santa Fe Rheumatology, Santa Fe
New YorkNYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department, Brooklyn
North CarolinaAccellacare of Hickory, Hickory
OhioUniversity Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division, Cleveland
Paramount Medical Research & Consulting, LLC, Middleburg Heights
PennsylvaniaPA Regional Center for Arthritis and Osteoporosis Research, Wyomissing
TennesseeWest Tennessee Research Institute, Jackson
TexasAccurate Clinical Research, Baytown
Novel Research | Bellaire Location, Bellaire
Novel Research | Bellaire Location, Bellaire
Accurate Clinical Research, Houston
Introscience Research | Northwest Houston Arthritis Center - Houston, TX, Houston
West Texas Clinical Research, Lubbock
Southwest Rheumatology Research, LLC | Mesquite, TX, Mesquite
Clinical Investigations of Texas, Plano
WashingtonArthritis Northwest, PLLC | Spokane, WA, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.