A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken 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
NCT06671483
Other Study ID Numbers:
TAK-279-PsA-3001
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: Active ComparatorDrug: Zasocitinib

Study Design

Study TypeInterventional
Actual Enrollment1088 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateMarch 2, 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 over-encapsulated tablets.
Zasocitinib Dose B
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Drug: Zasocitinib
Zasocitinib over-encapsulated tablets.
Active Comparator Dose C
Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
Drug: Active Comparator
Active comparator capsule.
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 over-encapsulated 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 ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
    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 of at Week 16 for zasocitinib Dose A and B compared to active comparator will be reported.
  9. Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A compared to Active Comparator
    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) for zasocitinib Dose A compared to active comparator at Week 16 will be reported.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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 SPARCC Enthesis Index = 0 through Week 16 for zasocitinib Dose A and B compared to placebo will be reported
  25. 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.
  26. 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.
  27. 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.
  28. Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
    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 active comparator will be reported.
  29. Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
    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 active comparator will be reported.
  30. 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 Active Comparator
    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 active comparator will be reported.
  31. 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 Active Comparator
    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 active comparator will be reported.
  32. 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 Active Comparator
    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 active comparator will be reported.
  33. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
    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 active comparator 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). 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).

Contacts and Locations

Sponsors and CollaboratorsTakeda
Locations
AARR- Chandler AZ | Chandler Arizona, United States, 85225Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Phoenix Arizona, United States, 85032Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Phoenix Arizona, United States, 85032Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Phoenix Arizona, United States, 85306First OC Dermatology Research Inc. | Fountain Valley California, United States, 92708Purushotham & Akther Kotha MD | La Mesa California, United States, 91942Triwest Research Associates LLC | La Mesa California, United States, 91942The Cohen Medical Centers | Thousand Oaks California, United States, 91360-3967Foothill Arthritis Clinic | Tujunga California, United States, 91042Medvin Clinical Research | Whittier California, United States, 90602-1005Denver Arthritis Clinic | Denver, CO | Denver Colorado, United States, 80230Arthritis & Rheumatic Disease Specialties (AARDS) | Aventura Florida, United States, 33180RASF- Clinical Research Center | Boca Raton Florida, United States, 33486-1390Clinical Research of West Florida | Clearwater, FL | Clearwater Florida, United States, 33765GNP Research, LLC | Hollywood, FL | Cooper City Florida, United States, 33024Driven Research LLC | Coral Gables Florida, United States, 33134-3901Tectum Medical Research | Davie Florida, United States, 33024Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research | Hialeah Florida, United States, 33016Bioresearch Partners | Miami Florida, United States, 33143HMD Research LLC | Orlando Florida, United States, 32819Millennium Research | Ormond Beach, FL | Ormond Beach Florida, United States, 32174IRIS Research and Development | Plantation, FL | Plantation Florida, United States, 33324Sarasota Arthritis Research Center | Sarasota Florida, United States, 34239West Broward Rheumatology Associates, Inc. | Tamarac Florida, United States, 33321Clinical Research of West Florida | Tampa, FL | Tampa Florida, United States, 33606Marietta Rheumatology Associates | Marietta Georgia, United States, 30060GSCP/CIS | Orland Park Illinois, United States, 60467Greater Chicago Specialty Physicians LLC/CIS | Schaumburg Illinois, United States, 60195Accurate Clinical Research, Inc. | Lake Charles | Lake Charles Louisiana, United States, 70605Klein & Associates, M.D., P.A. | Hagerstown Maryland, United States, 21740Henry Ford Health System-Rheumatology Department | Detroit Michigan, United States, 48202Michigan Rheumatology Group, P.C. - Grand Blanc Office | Grand Blanc Michigan, United States, 48439-2451Ash Research Clinic - Howell | Howell Michigan, United States, 48843June DO, PC Private Practice - Dr. Justus Fiechtner | Lansing Michigan, United States, 48911-4285Clinical Research Institute of Michigan | Saint Clair Shores Michigan, United States, 48081Saint Louis Rheumatology | St Louis Missouri, United States, 63119Albuquerque Center for Rheumatology PC | Albuquerque New Mexico, United States, 87102-1710Santa Fe Rheumatology | Santa Fe New Mexico, United States, 87505-1102NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department | Brooklyn New York, United States, 11201Accellacare of Hickory | Hickory North Carolina, United States, 28602University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division | Cleveland Ohio, United States, 44106Paramount Medical Research & Consulting, LLC | Middleburg Heights Ohio, United States, 44130PA Regional Center for Arthritis and Osteoporosis Research | Wyomissing Pennsylvania, United States, 19610-3206West Tennessee Research Institute | Jackson Tennessee, United States, 38305Accurate Clinical Research | Baytown Texas, United States, 77521Novel Research | Bellaire Location | Houston Texas, United States, 77024Novel Research | Bellaire Location | Houston Texas, United States, 77024Accurate Clinical Research | Houston Texas, United States, 77089Introscience Research | Northwest Houston Arthritis Center - Houston, TX | Houston Texas, United States, 77090West Texas Clinical Research | Lubbock Texas, United States, 79424Southwest Rheumatology Research, LLC | Mesquite, TX | Mesquite Texas, United States, 75150Clinical Investigations of Texas | Plano Texas, United States, 75075Arthritis Northwest, PLLC | Spokane, WA | Spokane Washington, United States, 99204Medical College of Wisconsin | Department of Medicine - Rheumatology Division | Milwaukee Wisconsin, United States, 53226-3522Université Libre de Bruxelles | Anderlecht Brussels Capital, Belgium, 1070University Hospital Ghent | Ghent Flanders, Belgium, 9000ReumaClinic Genk | Genk Limburg, Belgium, 3600St Pierre Brussels | Brussels , Belgium, 1000Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman | Liège , Belgium, 4000Diagnostic Consultative Centre - Focus-5 - LZIP EOOD | Sofia Sofia-Grad, Bulgaria, 1463Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia | Sofia Sofia-Grad, Bulgaria, 1606Centre of Rheumatology St. Irina | Sofia Sofia-Grad, Bulgaria, 1784Medical Center Medconsult Pleven OOD | Pleven , Bulgaria, 5800AES Partner Site -Plovdiv | Plovdiv , Bulgaria, 4000Medical Center Artmed OOD | Plovdiv, Bulgaria | Plovdiv , Bulgaria, 4000Diagnostic- Consultative Center- 1- Ruse EOOD | Rousse , Bulgaria, 7002Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria | Stara Zagora , Bulgaria, 6000Medical Center Zara-Med EOOD | Stara Zagora , Bulgaria, 6000El Centro de Estudios Reumatologicos (CER) | Providencia Santiago Metropolitan, Chile, 7500000Clinica Dermacross S.A. | Santiago Santiago Metropolitan, Chile, 7640881Centro de Estudios Clinicos | Santiago , Chile, 8320000CTR Estudios | Santiago , Chile, 8320000Centro Internacional de Estudios Clínicos | Santiago , Chile, 8420383Medicinski Centar Kuna and Peric | Zagreb City of Zagreb, Croatia, 10000Clinical Hospital Centre Osijek | Osijek , Croatia, 31000Clinical Hospital Center Rijeka | Rijeka , Croatia, 51000University Hospital Centre Split | Split , Croatia, 21000General Hospital Zadar | Zadar , Croatia, 23000Revmatologie s.r.o. | Brno, Czech Republic | Brno Czech Rep, Czechia, 63800L.K.N. Arthrocentrum, s.r.o. - Revmatologicka | Hlučín Czech Rep, Czechia, 92307Clintrial s.r.o. | Prague, Czech Republic | Prague Czech Rep, Czechia, 100 00Praglandia | Prague, Czech Republic | Prague Czech Rep, Czechia, 150 00MEDICAL Plus s.r.o. | Uherské Hradiště Czech Rep, Czechia, 68601CCR Ostrava | Ostrava Moravian-Silesian Region, Czechia, 702 00Pv Medical Services | Zlín NAP, Czechia, 760 01Revmatologicky ustav | Clinical Evaluation Department | Prague Prague, Czechia, 12800Pratia Pardubice a.s. | Pardubice , Czechia, 53002Innomedica OU | Tallinn, Estonia | Tallinn Harju, Estonia, 10117Center for Clinical and Basic Research | Tallinn Harju, Estonia, 10128Clinical Research Centre | Tartu, Estonia | Tartu Tartu, Estonia, 50106North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department | Tallinn , Estonia, 13419MediTrials OÜ | Tartu , Estonia, 50708Fachklinik Bad Bentheim | Bad Bentheim Lower Saxony, Germany, 48455Rheumzentrum Prof.Dr.med.Gunther Neeck | Bad Doberan Mecklenburg-Vorpommern, Germany, 18209Rheumazentrum Ratingen-Studienambulanz | Ratingen North Rhine-Westphalia, Germany, 40878Universitaetsklinikum Leipzig AoeR | Leipzig Saxony, Germany, 4103Rheumatologische Schwerpunktpraxis | Berlin, Germany | Berlin , Germany, 12161Städtisches Klinikum Dresden | Dresden , Germany, 01067MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg | Hamburg , Germany, 20095Medicover MVZ München Ost | München , Germany, 81667Porcika Klinika | Hódmezővásárhely Csongrad-Csanad, Hungary, 6800Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged Csongrad-Csanad, Hungary, 6720CMed Rehabilitacios es Diagnosztikai Kozpont | Székesfehérvár Fejér, Hungary, 8000Qualiclinic | Budapest, Hungary | Budapest , Hungary, 1036Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center | Székesfehérvár , Hungary, 8000Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary | Veszprém , Hungary, 8200Assuta Ashdod Medical Center | Ashdod Southern District, Israel, 7747629Barzilai Medical Center | Rheumatology Department | Ashkelon , Israel, 7830604Rambam Health Care Campus | Haifa , Israel, 3109601Galilee Medical Center | Rheumatology Unit | Nahariya , Israel, 2210001The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases | Ramat Gan , Israel, 5265601Tel Aviv Sourasky Medical Center | Tel Aviv , Israel, 6423906Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica | Torrette Ancona, Italy, 60126Fondazione PTV Policlinico Tor Vergata | Rome Lazio, Italy, 00133Policlinico Agostino Gemelli, UOC Reumatology | Rome Lazio, Italy, 168ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO | Milan Lombardy, Italy, 20122Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele | Milan Lombardy, Italy, 20132IRCCS Istituto Clinico Humanitas | Rozzano Milano, Italy, 20089Azienda Ospedale Università Padova | Padova Veneto, Italy, 35128Azienda Ospedaliera Universitaria Careggi | Florence , Italy, 50134Azienda Ospedaliero Universitaria Pisana | Pisa , Italy, 56126D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia | Liepāja , Latvia, 3401ORTO Clinic | Rheumatology Department | Riga , Latvia, LV-1005Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO) | Mexicali Estado de Baja California, Mexico, 21200iBiomed Guadalajara | Zapopan Guadalajara, Mexico, 44160Centro Integral en Reumatologia, S.A. de C.V. | Guadalajara Jalisco, Mexico, 44160Private Practice - Dr. Delfina Villanueva Quintero | Guadalajara Jalisco, Mexico, 44600Consultorio de Reumatologia | Gustavo Adolfo Madero Mexico City, Mexico, 07760HMG Hospital Coyoacan | Mexico City Mexico City, Mexico, 06720CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. | Mexico City Mexico City, Mexico, 11850Kohler and Milstein Research Yucatan | Mérida Yucatán, Mexico, 97070Hospitales Star Medica | Mérida Yucatán, Mexico, 97133Office of Cesar F. Pacheco-Tena, MD | Chihuahua City , Mexico, 31000CGM Research Trust | Christchurch Central Christchurch, New Zealand, 8013Aotearoa Clinical Trials | Auckland North Island, New Zealand, 2025North Shore Hospital | Auckland North Island, New Zealand, 6022Porter Rheumatology Ltd | Nelson South Island, New Zealand, 7010Waikato Hospital | Hamilton Waikato Region, New Zealand, 8011Pratia Poznań | Poznan Greater Poland Voivodeship, Poland, 60-192Centrum Medyczne Plejady | Krakow Lesser Poland Voivodeship, Poland, 30-363Pratia MCM Krakow | Krakow Lesser Poland Voivodeship, Poland, 30-727Krakowskie Centrum Medyczne | Krakow Lesser Poland Voivodeship, Poland, 31-501Centrum Medyczne Katowice - PRATIA | Katowice Lower Silesian Voivodeship, Poland, 40-081RCMed | Sochaczew, Poland | Sochaczew Masovian Voivodeship, Poland, 96-500Rheuma Medicus | Warsaw, Poland | Warsaw Masovian Voivodeship, Poland, 02-118MTZ Clinical Research Powered by PRATIA | Warsaw Masovian Voivodeship, Poland, 02-172Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic | Warsaw Masovian Voivodeship, Poland, 02-637Centrum Medyczne Reuma Park | Warsaw Masovian Voivodeship, Poland, 02-665ETG Warszawa Sp. z o.o. | Warsaw Masovian Voivodeship, Poland, 02-677Twoja Przychodnia Opolskie Centrum Medyczne | Opole Opole Voivodeship, Poland, 45-819INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland | Bialystok Podlaskie Voivodeship, Poland, 15-077Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty | Bialystok Podlaskie Voivodeship, Poland, 15-077Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik | Bialystok Podlaskie Voivodeship, Poland, 15-351Bif-Med s.c. NZOZ | Bytom Silesian Voivodeship, Poland, 41-902MICS Centrum Medyczne Torun | Torun Silesian Voivodeship, Poland, 87-100UNICA CR sp. z.o. o. | Dąbrówka Warmian-Masurian Voivodeship, Poland, 62-069Ambulatorium Sp. z o.o. | Elblag Warmian-Masurian Voivodeship, Poland, 82-300Etyka Osrodek Badan Klinicznych | Olsztyn, Poland | Olsztyn Warmian-Masurian Voivodeship, Poland, 10-117Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o. | Poznan Wielkopolska, Poland, 60-324Reumedika | Poznan, Poland | Poznan Wlkp, Poland, 60-446Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland | Poznan Woj. Wielkopolskie, Poland, 61-397Santa Familia PTG Lodz | Lodz, Poland | Lodz , Poland, 90-302FutureMeds | Lodz Center - Lodz, Poland | Lodz , Poland, 91-363Twoja Przychodnia | Nowa Sol, Poland | Nowa Sól , Poland, 67-100FutureMeds Wroclaw | Wroclaw , Poland, 53-673Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra | Coimbra Barcelona, Portugal, 3004-561Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho | Ponte de Lima Barcelona, Portugal, 4990-041Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E | Vila Nova de Gaia New Mexico, Portugal, 4434-502Hospital Garcia de Orta | Almada , Portugal, 2805-267Instituto Portugues de Reumatologia | Lisbon , Portugal, 1050-034Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department | Lisbon , Portugal, 1649-035Centro Reumatologico de Caguas | Caguas, PR | Caguas , Puerto Rico, 00725GCM Medical Group, PSC | San Juan, PR | San Juan , Puerto Rico, 00917The Catholic University of Korea | Suwon Gyeonggi-do, South Korea, 16247Ajou University Hospital | Clinical Trial Center | Suwon Gyeonggido, South Korea, 16499Asan Medical Center | Seoul , South Korea, 05505SMG - SNU Boramae Medical Center | Seoul , South Korea, 07061Kyung Hee University Hospital | Seoul , South Korea, 2447Hospital Universitario de Badajoz | Mérida Badajoz, Spain, 06006Corporacio Sanitaria Parc Tauli - Hospital de Sabadell | Sabadell Barcelona, Spain, 08208Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department | Santiago de Compostela Galicia, Spain, 15706Hospital Regional Universitario de Malaga | Málaga , Spain, 29010Hospital Universitario Virgen Macarena | Seville , Spain, 41009Hospital Clinico Universitario de Valencia | Valencia , Spain, 46010National Cheng Kung University | Tainan Tainan City, Taiwan, 701National Taiwan University Hospital | Zhong Zheng Qu Taipei City, Taiwan, 100Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department | New Taipei City , Taiwan, 220Chung Shan Medical University Hospital | Taichung , Taiwan, 40201Chi Mei Medical Center | Tainan , Taiwan, 710
Investigators
Study Director: Study Director, Takeda