A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Takeda
Sponsor
Takeda
Information Provided by (Responsible Party)
Takeda
Clinicaltrials.gov Identifier
NCT06671496
Other Study ID Numbers:
TAK-279-PsA-3002
First Submitted
October 30, 2024
First Posted
November 3, 2024
Last Update Posted
April 5, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Psoriatic Arthritis
Drug: ZasocitinibDrug: ZasocitinibDrug: Zasocitinib

Study Design

Study TypeInterventional
Actual Enrollment600 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)
Study Start DateMarch 9, 2025
Actual Primary Completion Date1yr 1w from now
Actual Study Completion Date1yr 8mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Zasocitinib Dose A
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Drug: Zasocitinib
Zasocitinib tablets.
Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Drug: Zasocitinib
Zasocitinib tablets.
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.
Drug: Zasocitinib
Zasocitinib tablets.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Secondary Outcome Measures
  1. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The MDA is defined as a composite outcome measure of 7 ClinROs and PROs used in PsA. Participants are classified as achieving MDA if they fulfil 5 of 7 outcome measures: TJC68 less than or equal to (\<=) 1, SJC66 \<=1, psoriasis area and severity index (PASI) score \<=1 or body surface area (BSA) affected by psoriasis \<=3%, PtGA of PsA Pain score \<=15, PtGA of PsA score \<=20, HAQ-DI \<=0.5, and Leeds Enthesitis Index (LEI) \<=1. Percentage of participants achieving MDA at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  2. Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    A PASI-75 response is defined as \>=75% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-75 response (in participants with a baseline \>=3% body surface area \[BSA\]) for zasocitinib Dose A and B compared to placebo at Week 16 will be reported.
  3. Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR50 response is defined as: \>= 50% improvement from baseline in both SJC66 and TJC68, and \>=50% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR50 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  4. Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The HAQ-DI is defined as a 20-item PRO measure used to assess functional ability over the past week across 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of these categories, participant reports the amount of difficulty they have in performing 2 or 3 specific activities on a 4-point scale (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do) The use of assistive devices and personal assistance are also noted. The HAQ-DI score is calculated as the mean of the category scores (0 = no disability, 3 = completely disabled), with 0 being the most desirable outcome and 3 as the least desirable. Participants must have scores for at least 6 categories for the HAQ-DI to be computed. Change from baseline in the HAQ-DI score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  5. Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR70 response is defined as: \>=70% improvement from baseline in both SJC66 and TJC68, and \>=70% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR70 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  6. Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A Compared to Placebo
    The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score PCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 PCS score at Week 16 for zasocitinib Dose A compared to placebo will be reported.
  7. Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo
    The FACIT-fatigue score is defined as a 13-item PRO measure that assesses the severity of self-reported fatigue and its impact on daily functioning over the past 7 days. It includes items measuring tiredness, weakness, listlessness, lack of energy, and the effects on activities such as sleep and social interactions. Each item is rated on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The total score ranges from 0 to 52, with higher scores indicating less fatigue. Change from baseline in the FACIT- fatigue score at Week 16 for zasocitinib Dose A compared to placebo will be reported.
  8. Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The LEI is defined as a 6-item ClinRO measure specifically developed for PsA. It assesses the presence or absence of pain/tenderness when 4 kilograms per centimeter square (kg/cm\^2) of pressure is applied to 6 enthesial sites: the lateral epicondyles, medial femoral condyles, and Achilles tendon insertions on both sides of the body. Tenderness at each site is recorded on a dichotomous scale (0 = non-tender, 1 = tender). The total score is the sum of tender sites, ranging from 0 to 6, with a higher score indicating a greater enthesitis burden. Percentage of participants achieving LEI =0 (in participants with a baseline LEI \>=1) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  9. Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR response is defined as: improvement from baseline in both SJC66 and TJC68, and improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain (0-100 visual analogue scale \[VAS\]); PtGA of PsA (0-100 VAS); PGA of PsA (0-100 VAS); participant's assessment of physical function as measured by HAQ-DI (0-3 scale); hsCRP. Change from baseline in individual components of ACR response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  10. Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The LDI is defined as a ClinRO measure use to assess the presence of dactylitis. It involves measuring the circumference of all 20 digits using a dactylometer, with measurements taken around the proximal phalanx as close to the web space as possible. Moderate pressure is applied to assess tenderness or pain in the affected digits. Tenderness is scored on a binary scale (0 = non-tender, 1 = tender). Only digits with a circumference ratio exceeding 10% are considered to have dactylitis. A higher score indicates worse dactylitis. Percentage of participants achieving LDI =0 (in participants with a baseline LDI \>=1) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  11. Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 4 and 8 for Zasocitinib Dose A and B Compared to Placebo
    A PASI-75 response is defined as \>=75% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-75 response (in participants with a baseline \>=3% BSA) at Week 8 for zasocitinib Dose A and B compared to placebo will be reported.
  12. Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    A PASI-90 response is defined as \>=90% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-90 response (in participants with a baseline \>=3% BSA) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  13. Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    A PASI-100 response is defined as \>=100% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-100 response (in participants with a baseline \>=3% BSA) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  14. Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    ACR responses measure improvement in multiple criteria, a composite COA with ClinROs and PROs. An ACR50 response is \>=50% improvement in SJC66 and TJC68, and 3 of 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA, HAQ-DI, hsCRP. A PASI-100 response is \>=100% improvement in the PASI score from baseline. It's a ClinRO measuring psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored from 0 (no involvement) to 4 (very marked involvement). PASI scores range from 0 to 72, with \<=3 as mild, \>=3 to 15 as moderate, and \>=15 as severe disease. Percentage of participants achieving ACR50 and PASI-100 response (in participants with a baseline \>=3% BSA) simultaneously at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  15. Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    Static physician's global assessment (sPGA) is defined as a 5-point ClinRO measure used to assess the current state of psoriasis based on severity of erythema, induration, and scaling. The total sPGA score ranges from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe, with higher scores indicating greater disease severity. Each lesion characteristic (erythema, induration, and scaling) is graded separately on a 5-point scale: erythema (0 = no evidence to 4 = bright red coloration), induration (0 = no evidence to 4 = severe plaque elevation), and scaling (0 = no evidence to 4 = thick scaling). Lesion scores for erythema, induration, and scaling are averaged and rounded to nearest whole number to compute total score. Percentage of participants achieving sPGA response of clear (0) or almost clear (1) with \>=2-point decrease from baseline (in participants with a baseline sPGA \>=2) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  16. Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The HAQ-DI is defined as a 20-item PRO measure used to assess functional ability over the past week across 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each category includes 2-3 activities rated on a 4-point scale (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). Assistive devices and personal assistance are also noted. The HAQ-DI score is calculated as the mean of the category scores (0 = no disability, 3 = completely disabled), with scores of 0-1 indicating mild-to-moderate disability, 1-2 moderate-to-severe, and 2-3 severe-to-very severe disability. Participants must have scores for at least 6 categories for the HAQ-DI to be computed. Percentage of responders achieving minimal clinically important differences (reduction of \>=0.35 from baseline) in HAQ-DI score from baseline at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  17. Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 MCS score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  18. Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The PsAID-12 is defined as a 12-item PRO measure that assesses symptoms such as pain, fatigue, and skin problems and the impact of PsA on the participant's life over the past week. It covers areas including work and/or leisure activities, physical activities, sleep, anxiety, embarrassment or shame, social participation, and depression. The response options are rated on a numerical rating scale (NRS) from 0 (none/no difficulty) to 10 (extreme difficulty), with higher scores indicating a greater impact of the disease. Change from baseline in PsAID-12 total score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  19. Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The DAPSA is defined as a composite measure of peripheral joint disease activity that includes ClinROs, PROs, and a laboratory test. DAPSA is calculated as the sum of the following components: tender joint count (0-68), swollen joint count (0-66), hsCRP level (milligrams per deciliter \[mg/dL\]), PtGA of PsA pain (0-100 VAS), and PtGA of PsA (0-100 VAS). DAPSA cutoffs for disease activity are: remission (\<=4), low disease activity (\>4 to \<=14), moderate disease activity (\>14 to \<=28), and high disease activity (\>28). Change from baseline in DAPSA score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  20. Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The DAS28 with high-sensitivity C-reactive protein is defined as a derived index combining the tender joint count (28 joints), swollen joint count (28 joints), hsCRP, and PtGA of PsA. The 28-joint count includes the shoulder, elbow, wrist, metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5 of both upper extremities, and the knee joints of both lower extremities. The DAS28 score ranges from 0 to 10, with higher scores indicating greater disease activity. Change from baseline in DAS28 C-reactive protein score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  21. Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The PGA-F is defined as a ClinRO measure assessing the severity of fingernail PsO. It evaluates nail bed signs (onycholysis, hyperkeratosis, erythema, splinter hemorrhages) and nail matrix signs (pitting, ridging, discoloration). Clinicians rate the severity using categories: clear (0), minimal (1), mild (2), moderate (3), and severe (4). The total score is based on the area with the most involvement (nail bed or matrix), ranging from 0 (clear) to 4 (very severe), with higher scores indicating more severe fingernail PsO. Change from baseline in PGA-F score in participants with PGA-F \>0 from baseline at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
  22. Percentage of Participants Achieving a Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesis Index = 0 through Week 16 for Zasocitinib Dose A and B Compared to Placebo
    The SPARCC Enthesis Index is a ClinRO measure that assesses the presence or absence of pain/tenderness when 4 kg/cm\^2 of pressure is applied to 18 enthesial sites across the following 9 bilateral sites: Achilles tendons, plantar fascia insertion at the calcaneus, greater tuberosity of the humerus, medial epicondyles, lateral epicondyles, greater trochanter, quadriceps insertion, inferior patella, and tibial tuberosity. Tenderness at each site is recorded as either present (1) or absent (0). Total score is the sum of score from each site, ranging from 0 to 16, with higher scores indicating greater enthesis burden. Percentage of participants achieving a SPARCC Enthesis Index = 0 through Week 16 for zasocitinib Dose A and B compared to placebo will be reported
  23. Percentage of Participants Achieving ACR20 Response at Week 8 for Zasocitinib Dose A and B Compared to Placebo
    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR20 response is defined as: \>= 20% improvement from baseline in both SJC66 and TJC68, and \>=20% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR20 response at Week 8 for zasocitinib Dose A and B compared to placebo will be reported.
  24. Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo
    The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score PCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 PCS score at Week 16 for zasocitinib Dose B compared to placebo will be reported.
  25. Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo
    The FACIT-fatigue score is defined as a 13-item PRO measure that assesses the severity of self-reported fatigue and its impact on daily functioning over the past 7 days. It includes items measuring tiredness, weakness, listlessness, lack of energy, and the effects on activities such as sleep and social interactions. Each item is rated on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The total score ranges from 0 to 52, with higher scores indicating less fatigue. Change from baseline in the FACIT- fatigue score at Week 16 for zasocitinib Dose B compared to placebo will be reported.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Age: 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). 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), OR 3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.
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).

Contacts and Locations

Sponsors and CollaboratorsTakeda
Locations
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Mesa Arizona, United States, 85210Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Phoenix Arizona, United States, 85032Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Tucson Arizona, United States, 85748Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA | Covina California, United States, 91722RASF- Clinical Research Center | Boca Raton Florida, United States, 33486-1390Direct Helpers Medical Center | Hialeah Florida, United States, 33012IRIS Research and Development | Plantation, FL | Plantation Florida, United States, 33324BayCare Medical Group | St. Petersburg Florida, United States, 33705North Georgia Rheumatology Group PC | Lawrenceville Georgia, United States, 30046Clinic of Robert Hozman | Skokie Illinois, United States, 60076Graves Gilbert Clinic | Bowling Green Kentucky, United States, 42101Johns Hopkins Hospital | Baltimore Maryland, United States, 21205Advanced Rheumatology PC | Lansing, MI | Lansing Michigan, United States, 48910-5894AARR- Kansas City Physician Partners | Kansas City Missouri, United States, 85032DJL Clinical Research | Charlotte, NC | Charlotte North Carolina, United States, 28210University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division | Cleveland Ohio, United States, 44106Altoona Center for Clinical Research | Ducansville, PA | Duncansville Pennsylvania, United States, 16635AARR- Lone Star Arthritis & Rheumatology Associates | Fort Worth Texas, United States, 76109Biopharma Informatic | Hassan | Houston Texas, United States, 77089Advanced Rheumatology of Houston - The Woodlands | The Woodlands Texas, United States, 77382Swedish Rheumatology Research | Seattle Washington, United States, 98122Instituto de Investigaciones Clinicas Quilmes | Quilmes Buenos Aires, Argentina, B1878Clinica Regional del Sud S.A. | Río Cuarto Córdoba Province, Argentina, X5804GAOCentro de Investigaciones Reumatologicas | San Miguel de Tucumán Tucumán Province, Argentina, 4000CIMER | San Miguel de Tucumán Tucumán Province, Argentina, T4000Hospital General de Agudo Jose Maria Ramos Mejia | Buenos Aires , Argentina, C1221ADCAPRILLUS Asistencia e Investigacion Clinica | Buenos Aires , Argentina, C1406AGAConsultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina | Córdoba , Argentina, X5000CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica | San Juan , Argentina, 5400Royal Prince Alfred Hospital | Camperdown New South Wales, Australia, NSW 2050Westmead Hospital | Westmead New South Wales, Australia, 2145Sunshine Coast University Private Hospital | Clinical Trials | Sippy Downs Queensland, Australia, QLD 4575The Queen Elizabeth Hospital | Rheumatology Department | Woodville South South Australia, Australia, SA 5011Fiona Stanley Hospital | Palmyra Dc Western Australia, Australia, 6961Colin Bayliss Research and Teaching Unit | Victoria Park Western Australia, Australia, WA 6100CMIP-Centro Mineiro de Pesquisa Ltda | Juiz de Fora Minas Gerais, Brazil, 36010-570Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica | Uberlândia Minas Gerais, Brazil, 38405-320EDUMED - Educacao em Saude SS Ltda | Curitiba Paraná, Brazil, 80440-210LMK Servicos Medicos Sociedade Simples | Porto Alegre Rio Grande do Sul, Brazil, 90480-000Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department | São José do Rio Preto São Paulo, Brazil, 15090-000CEPIC - Centro Paulista de Investigacao Clinica | São Paulo , Brazil, 04266-010Niagara Rheumatology Research Centre | Ontario, Canada | Niagara Falls Ontario, Canada, L2E 6A6University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases | Toronto Ontario, Canada, M5T 2S8G.R.M.O. Inc. | Québec Quebec, Canada, G1V 3M7The First Affiliated Hospital Of Bengbu Medical College | Bengbu Anhui, China, 233004Xuanwu Hospital Capital Medical University | Beijing Beijing Municipality, China, 100053Peking University Third Hospital | Beijing Beijing Municipality, China, 100191Peking Union Medical College Hospital | Beijing Beijing Municipality, China, 100730The First Affiliated Hospital of Xiamen University | Xiamen Fujian, China, 361003Guangzhou First People's Hospital | Guangzhou Guandong, China, 519180Shenzhen People's Hospital | Shenzhen Guangdong, China, 518020The First Affiliated Hospital of Henan University of Science and Technology | Luoyang Henan, China, 471000Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST) | Wuhan Hubei, China, 430022Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital | Zhuzhou Hunan, China, 412007Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital | Baotou Shi Inner Mongolia, China, 014010The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University) | Hangzhou Jiangsu, China, 215005Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital) | Nanjing Jiangsu, China, 210029Affiliated Hospital of Nantong University | Nantong Jiangsu, China, 226001Northern Jiangsu People's Hospital | Yangzhou Jiangsu, China, 225007Jiujiang No.1 People's Hospital | Jiujiang Shi Jiangxi, China, 332000The First Affiliated Hospital of Nanchang University | Nanchang Jiangxi, China, 330006The Second Affiliated Hospital of Nanchang University | Nanchang Jiangxi, China, 330008Jiangxi Pingxiang People's Hospital | Pingxiang Pingxiang, China, PingxiangThe 2nd Hospital of Xi'An Jiaotong University | Xi'an Shan'xi, China, 710004Linyi People's Hospital | Linyi Shi Shandong, China, 276000Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Pudong New District Shanghai Municipality, China, 200127First Hospital of Shanxi Medical University | Taiyuan Shanxi, China, 030001Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital) | Taiyuan Shanxi, China, 030605West China Hospital of Sichuan University | Chengdu Sichuan, China, 610041Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chengdu , China, 610072Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University) | Guangzhou , China, 510630Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | Shanghai , China, 200052Wenzhou Medical University (WMU) - The First Affiliated Hospital | Wenzhou , China, 325000Clinique de l'Infirmerie Protestante | Caluire-et-Cuire Auvergne-Rhône-Alpes, France, 69300CHU Toulouse | Toulouse Haute Garonne, France, 31059CHRU de Tours | Tours Indre Et Loire, France, 37044CHU de Reims | Reims Marne, France, " 51100"Hopital Nord | Saint-Etienne , France, 13015Universitatsklinikum Leipzig | Leipzig Saxony, Germany, 4103Private Practice - Dr. Maren Sieburg | Magdeburg Saxony-Anhalt, Germany, 39104ISA - Interdisciplinary Study Association | Berlin , Germany, 10789MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg | Hamburg , Germany, 20095Rheumazentrum Ruhrgebiet | Herne , Germany, 44649Kojunkai Social Medical Corporation Daido Clinic | Minami-ku, Nagoya-shi Aichi-ken, Japan, 457-8511Nagoya City University Hospital | Nagoya Aichi-ken, Japan, 467-8602Hokkaido University Hospital | Sapporo Hokkaido, Japan, 060-8648Fukuoka University Hospital | Fukuoka Hukuoka, Japan, 814-0180Kita-Harima Medical Center | Ono-shi Hyōgo, Japan, 675-1392Mie University Hospital | Tsu, Mie Mie-ken, Japan, 514-8507National University Corporation Tohoku University Tohoku University Hospital | Sendai Miyagi, Japan, 980-8574Tohoku Medical and Pharmaceutical University Hospital | Sendai Miyagi, Japan, 983-8512Sasebo Chuo Hospital | Sasebo-shi Nagasaki, Japan, 857-1195Nippon Life Hospital | Nishi Ward Osaka, Japan, 550-0006St. Luke's International Hospital | Chuo-ku Tokyo, Japan, 104-8560National Hospital Organization Tokyo Medical Center | Meguro-Ku Tokyo, Japan, 152-8902Toho University Ohashi Medical Center | Meguro-ku Tokyo, Japan, 153-8515Tokyo Medical University Hospital | Shinjuku-Ku Tokyo, Japan, 160-0023Kyorin University Hospital | Mitaka-shi Tokyo-To, Japan, 181-8611MICS Centrum Medyczne Bydgoszcz | Bydgoszcz Kuyavian-Pomeranian Voivodeship, Poland, 85-090Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland | Krakow Lesser Poland Voivodeship, Poland, 30-033Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki | Wroclaw Lower Silesian Voivodeship, Poland, 50-244dermMedica Sp. z o.o. | Wroclaw Lower Silesian Voivodeship, Poland, 51-503Centrum Medyczne Pratia Gdynia | Gdynia Pomeranian Voivodeship, Poland, 81-338Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland | Częstochowa Silesian Voivodeship, Poland, 42-217Centrum Kliniczno Badawcze | Elblag, Poland | Elblag Warmian-Masurian Voivodeship, Poland, 82-300Medyczne Centrum Hetmańska Piotr Leszczyński | Poznan Wielkopolska, Poland, 60-128Clinical Research Center Sp z o o Medic-R Sp K | Poznan Wielkopolska, Poland, 61-731Klinika Reuma Park | Warsaw Wybierz Województwo, Poland, 02-665Zespol Poradni Specjalistycznych Reumed | Lublin , Poland, 20-607Hospital Universitario Araba - Sede Hospital Txagorritxu | Vitoria-Gasteiz Basque Country, Spain, 1009Hospital Universitario Marques de Valdecilla | Rheumatology Department | Santander Cantabria, Spain, 39008Accellacare Alcobendas | Alcobendas Madrid, Spain, 28100Hospital Universitario La Paz | Madrid , Spain, 28046Hospital Universitario de Canarias | Santa Cruz de Tenerife , Spain, 38320Hospital Quirónsalud Sagrado Corazón | Seville , Spain, 41013King's College Hospital | London Greater London, United Kingdom, SE5 9RSCoventry and Warwickshire Partnership NHS Trust | Coventry West Midlands, United Kingdom, CV2 2DXSt Luke's Hospital - UK | Bradford West Yorkshire, United Kingdom, BD5 0NAThe Princess Alexandra Hospital NHS Trust | Harlow , United Kingdom, CM20 1QXOxford University Hospitals NHS Trust | Oxford , United Kingdom, OX3 9RPHaywood Hospital | Stoke-on-Trent , United Kingdom, ST6 7AGThe Royal Wolverhampton NHS Trust | Wolverhampton , United Kingdom, WV10 0QP
Investigators
Study Director: Study Director, Takeda