A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
- Conditions
- Psoriatic Arthritis
- Interventions
- Registration Number
- NCT06671483
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1088
Age:
-
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:
-
The participant has had signs and symptoms consistent with PsA for at least 3 months.
-
The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
-
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.
-
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:
-
The participant has had at least one of the following:
- Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
- Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
PsA and PsO:
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zasocitinib Dose B Zasocitinib Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52. Placebo + Zasoctinib Zasocitinib 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. Zasocitinib Dose A Zasocitinib Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52. Active Comparator Dose C Active Comparator Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52. Placebo + Zasoctinib Placebo 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo At Week 16 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
Name Time Method Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo At Week 16 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.
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 Baseline, at Week 16 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.
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo At Week 16 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.
Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo Baseline, at Week 16 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.
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo At Week 16 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.
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 Baseline, at Week 16 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.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo Baseline, at Week 16 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.
Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator At Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 8 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo Baseline, at Week 16 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.
Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo Baseline, at Week 16 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.
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator At Week 16 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.
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator At Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
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 Baseline, at Week 16 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.
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator At Week 16 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.
Trial Locations
- Locations (196)
FutureMeds Wroclaw
🇵🇱Wrocław, Poland
AARR- Chandler AZ
🇺🇸Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
🇺🇸Phoenix, Arizona, United States
First OC Dermatology Research Inc.
🇺🇸Fountain Valley, California, United States
Purushotham & Akther Kotha MD
🇺🇸La Mesa, California, United States
Triwest Research Associates LLC
🇺🇸La Mesa, California, United States
VA Northern California Health Care System | Sacramento VA Medical Center
🇺🇸Mather, California, United States
Amicis Research Center | Northridge, CA
🇺🇸Northridge, California, United States
Biosolutions Research Center | La Mesa, CA
🇺🇸Poway, California, United States
The Cohen Medical Centers
🇺🇸Thousand Oaks, California, United States
Foothill Arthritis Clinic
🇺🇸Tujunga, California, United States
Amicus Arthritis & Osteoporosis Center (AAOC)
🇺🇸Whittier, California, United States
Denver Arthritis Clinic | Denver, CO
🇺🇸Denver, Colorado, United States
Arthritis & Rheumatic Disease Specialties (AARDS)
🇺🇸Aventura, Florida, United States
RASF- Clinical Research Center
🇺🇸Boca Raton, Florida, United States
Clinical Research of West Florida | Clearwater, FL
🇺🇸Clearwater, Florida, United States
GNP Research, LLC | Hollywood, FL
🇺🇸Cooper City, Florida, United States
Driven Research LLC
🇺🇸Coral Gables, Florida, United States
Tectum Medical Research
🇺🇸Davie, Florida, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
🇺🇸Hialeah, Florida, United States
LeJenue Research Associates PLLC | Miami, FL
🇺🇸Miami, Florida, United States
Bioresearch Partners
🇺🇸Miami, Florida, United States
HMD Research LLC | Orlando, FL
🇺🇸Orlando, Florida, United States
Millennium Research | Ormond Beach, FL
🇺🇸Ormond Beach, Florida, United States
IRIS Research and Development | Plantation, FL
🇺🇸Plantation, Florida, United States
Sarasota Arthritis Research Center
🇺🇸Sarasota, Florida, United States
West Broward Rheumatology Associates, Inc.
🇺🇸Tamarac, Florida, United States
Clinical Research of West Florida | Tampa, FL
🇺🇸Tampa, Florida, United States
Marietta Rheumatology Associates
🇺🇸Marietta, Georgia, United States
Greater Chicago Specialty Physicians LLC/CIS
🇺🇸Schaumburg, Illinois, United States
Accurate Clinical Research, Inc. | Lake Charles
🇺🇸Lake Charles, Louisiana, United States
Klein & Associates, M.D., P.A.
🇺🇸Hagerstown, Maryland, United States
Henry Ford Health System-Rheumatology Department
🇺🇸Detroit, Michigan, United States
Michigan Rheumatology Group, P.C. - Grand Blanc Office
🇺🇸Grand Blanc, Michigan, United States
June DO, PC Private Practice - Dr. Justus Fiechtner
🇺🇸Lansing, Michigan, United States
Clinical Research Institute of Michigan
🇺🇸Saint Clair Shores, Michigan, United States
Ascent Urgent Care & Walk In Clinic
🇺🇸Saline, Michigan, United States
Saint Louis Rheumatology
🇺🇸Saint Louis, Missouri, United States
Albuquerque Center for Rheumatology PC
🇺🇸Albuquerque, New Mexico, United States
Inspire Santa Fe Medical Group
🇺🇸Santa Fe, New Mexico, United States
NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department
🇺🇸Brooklyn, New York, United States
Accellacare of Hickory
🇺🇸Hickory, North Carolina, United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
🇺🇸Cleveland, Ohio, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
PA Regional Center for Arthritis and Osteoporosis Research
🇺🇸Wyomissing, Pennsylvania, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Novel Research | Bellaire Location
🇺🇸Houston, Texas, United States
Introscience Research | Northwest Houston Arthritis Center - Houston, TX
🇺🇸Houston, Texas, United States
West Texas Clinical Research
🇺🇸Lubbock, Texas, United States
Southwest Rheumatology Research, LLC | Mesquite, TX
🇺🇸Mesquite, Texas, United States
Clinical Investigations of Texas
🇺🇸Plano, Texas, United States
Arthritis Northwest, PLLC | Spokane, WA
🇺🇸Spokane, Washington, United States
Medical College of Wisconsin | Department of Medicine - Rheumatology Division
🇺🇸Milwaukee, Wisconsin, United States
Université Libre de Bruxelles
🇧🇪Anderlecht, Brussels, Belgium
University Hospital Ghent
🇧🇪Gent, Flanders, Belgium
RerumaClinic Genk
🇧🇪Genk, Limburg, Belgium
St Pierre Brussels
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
🇧🇬Sofia, Sofia-Grad, Bulgaria
Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia
🇧🇬Sofia, Sofia-Grad, Bulgaria
Centre of Rheumatology St. Irina
🇧🇬Sofia, Sofia-Grad, Bulgaria
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
AES Partner Site -Plovdiv
🇧🇬Plovdiv, Bulgaria
Medical Center Artmed OOD | Plovdiv, Bulgaria
🇧🇬Plovdiv, Bulgaria
Diagnostic- Consultative Center- 1- Ruse EOOD
🇧🇬Ruse, Bulgaria
Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria
🇧🇬Stara Zagora, Bulgaria
Medical Center Zara-Med EOOD
🇧🇬Stara Zagora, Bulgaria
Clinica Dermacross S.A.
🇨🇱Santiago, Region Metropolitana De Santiago, Chile
El Centro de Estudios Reumatologicos (CER)
🇨🇱Providencia, Santiago, Chile
Centro de Estudios Clinicos
🇨🇱Santiago, Chile
CTR Estudios
🇨🇱Santiago, Chile
Centro Internacional de Estudios Clínicos
🇨🇱Santiago, Chile
Centro Integral de Reumatologia Circaribe S.A.S.
🇨🇴Barranquilla, Atlantico, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
🇨🇴Bogota D.C., Cundinamarca, Colombia
Fundacion Santa Fe de Bogota
🇨🇴Bogotá D.C., Cundinamarca, Colombia
Servimed S.A.S
🇨🇴Bucaramanga, Cundinamarca, Colombia
Preventive Care S.A.S.
🇨🇴Chia, Cundinamarca, Colombia
Medicinski Centar Kuna and Peric
🇭🇷Zagreb, Grad Zagreb, Croatia
Clinical Hospital Centre Osijek
🇭🇷Osijek, Croatia
Clinical Hospital Center Rijeka
🇭🇷Rijeka, Croatia
University Hospital Centre Split
🇭🇷Split, Croatia
General Hospital Zadar
🇭🇷Zadar, Croatia
Revmatologie s.r.o. | Brno, Czech Republic
🇨🇿Brno, Czech Rep, Czechia
L.K.N. Arthrocentrum, s.r.o. - Revmatologicka
🇨🇿Hlučín, Czech Rep, Czechia
Praglandia | Prague, Czech Republic
🇨🇿Prague, Czech Rep, Czechia
Clintrial s.r.o. | Prague, Czech Republic
🇨🇿Praha 10, Czech Rep, Czechia
MEDICAL Plus s.r.o.
🇨🇿Uherske Hradiste, Czech Rep, Czechia
CCR Ostrava
🇨🇿Ostrava, Moravskoslezský Kraj, Czechia
Pv Medical Services
🇨🇿Zlin, NAP, Czechia
Revmatologicky ustav | Clinical Evaluation Department
🇨🇿Praha 2, Prague, Czechia
Pratia Pardubice a.s.
🇨🇿Pardubice, Czechia
Innomedica OU | Tallinn, Estonia
🇪🇪Tallinn, Harjumaa, Estonia
Center for Clinical and Basic Research
🇪🇪Tallinn, Harjumaa, Estonia
Clinical Research Centre | Tartu, Estonia
🇪🇪Tartu, Tartumaa, Estonia
North Estonia Medical Centre | Mustamae Building - Internal Medicine Clinic - Rheumatology Department
🇪🇪Tallinn, Estonia
MediTrials OÜ
🇪🇪Tartu, Estonia
Rheumzentrum Prof.Dr.med.Gunther Neeck
🇩🇪Bad Doberan, MV, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Niedersachsen, Germany
Rheumazentrum Ratingen-Studienambulanz
🇩🇪Ratingen, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig AoeR
🇩🇪Leipzig, Sachsen, Germany
Rheumatologische Schwerpunktpraxis | Berlin, Germany
🇩🇪Berlin, Germany
Städtisches Klinikum Dresden
🇩🇪Dresden, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
🇩🇪Hamburg, Germany
Praxis für Klinische Studien | Hamburg, Germany
🇩🇪Hamburg, Germany
Medicover MVZ München Ost
🇩🇪München, Germany
Porcika Klinika
🇭🇺Hodmezovasarhely, Csongrad-Csanad, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
🇭🇺Szeged, Csongrad-Csanad, Hungary
CMed Rehabilitacios es Diagnosztikai Kozpont
🇭🇺Szekesfehervar, Fejer, Hungary
Qualiclinic | Budapest, Hungary
🇭🇺Budapest, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktató Korhaz | Rheumatology Department - Arthritis Center
🇭🇺Szekesfehervar, Hungary
Vital Medical Center Medical Center and Dental Center | Reumatologia - Veszprem, Hungary
🇭🇺Veszprem, Hungary
Assuta Ashdod Medical Center
🇮🇱Ashdod, HaDarom, Israel
Barzilai Medical Center | Rheumatology Department
🇮🇱Ashkelon, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Galilee Medical Center | Rheumatology Unit
🇮🇱Nahariya, Israel
The Chaim Sheba Medical Center - The Zabludowicz Center for Autoimmune Diseases
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
🇮🇹Torrette, Ancona, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
Policlinico Agostino Gemelli, UOC Reumatology
🇮🇹Roma, Lazio, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
🇮🇹Milan, Lombardia, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
🇮🇹Milan, Lombardia, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Universita Degli Studi Di Padova
🇮🇹Padova, Padua, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
The Catholic University of Korea
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital | Clinical Trial Center
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
SMG - SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia
🇱🇻Liepaja, Latvia
ORTO Clinic | Rheumatology Department
🇱🇻Riga, Latvia
Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)
🇲🇽Mexicali, Baja California, Mexico
HMG Hospital Coyoacan
🇲🇽Ciudad de Mexico, Cdmx, Mexico
Consultorio de Reumatologia
🇲🇽Gustavo A. Madero, Distrito Federal, Mexico
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
🇲🇽Mexico, Distrito Federal, Mexico
iBiomed Guadalajara
🇲🇽Zapopan, Guadalajara, Mexico
Centro Integral en Reumatologia, S.A. de C.V.
🇲🇽Guadalajara, Jalisco, Mexico
Private Practice - Dr. Delfina Villanueva Quintero
🇲🇽Guadalajara, Jalisco, Mexico
Kohler and Milstein Research Yucatan
🇲🇽Merida, Yucatan, Mexico
Hospitales Star Medica
🇲🇽Merida, Yucatan, Mexico
Office of Cesar F. Pacheco-Tena, MD
🇲🇽Chihuahua, Mexico
CGM Research Trust
🇳🇿Christchurch Central, Christchurch, New Zealand
Aotearoa Clinical Trials
🇳🇿Auckland, North Island, New Zealand
North Shore Hospital
🇳🇿Auckland, North Island, New Zealand
Porter Rheumatology Ltd
🇳🇿Nelson, South Island, New Zealand
Waikato Hospital
🇳🇿Hamilton, Waikato, New Zealand
Centrum Medyczne Katowice - PRATIA
🇵🇱Katowice, Dolnoslaskie, Poland
WroMedica Centrum Zdrowia | Rheumatology Clinic
🇵🇱Wroclaw, Dolnoslaskie, Poland
Pratia MCM Krakow
🇵🇱Krakow, Malopolskie, Poland
Krakowskie Centrum Medyczne
🇵🇱Krakow, Malopolskie, Poland
Centrum Medyczne Plejady
🇵🇱Kraków, Malopolskie, Poland
RCMed | Sochaczew, Poland
🇵🇱Sochaczew, Mazowieckie, Poland
Klinika Reuma Park
🇵🇱Warsaw, Mazowieckie, Poland
Rheuma Medicus | Warsaw, Poland
🇵🇱Warszawa, Mazowieckie, Poland
MTZ Clinical Research Powered by PRATIA
🇵🇱Warszawa, Mazowieckie, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Centrum Wsparcia Badań Klinic
🇵🇱Warszawa, Mazowieckie, Poland
ETG Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Twoja Przychodnia | Opole, Poland
🇵🇱Opole, Opolskie, Poland
INTER CLINIC Piotr Adrian Klimiuk | Bialystok, Poland
🇵🇱Bialystok, Podlaskie, Poland
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
🇵🇱Bialystok, Podlaskie, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
🇵🇱Bialystok, Podlaskie, Poland
MICS Centrum Medyczne Torun
🇵🇱Torun, Silesia, Poland
Etyka Osrodek Badan Klinicznych | Olsztyn, Poland
🇵🇱Olsztyn, Warmia-Masuria, Poland
UNICA CR sp. z.o. o.
🇵🇱Dabrowka, Warmian-Masurian Voivodeship, Poland
Ambulatorium Sp. z o.o.
🇵🇱Elbląg, Warminsko-Mazurskie, Poland
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.
🇵🇱Poznan, Wielkopolska, Poland
Reumedika | Poznan, Poland
🇵🇱Poznan, Wlkp, Poland
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj | Poznan, Poland
🇵🇱Poznan, Woj. Wielkopolskie, Poland
Pratia Poznań
🇵🇱Poznan, Wojewodztwo Wielkopolskie, Poland
Twoja Przychodnia | Nowa Sol, Poland
🇵🇱Nowa Sól, Poland
Santa Familia PTG Lodz | Lodz, Poland
🇵🇱Łódź, Poland
FutureMeds | Lodz Center - Lodz, Poland
🇵🇱Łódź, Poland
Bif-Med s.c. NZOZ
🇵🇱Bytom, Śląskie, Poland
Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
🇵🇹Ponte de Lima, Barcelona, Portugal
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
🇵🇹Vila Nova de Gaia, New Mexico, Portugal
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Instituto Portugues de Reumatologia
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitario de Lisboa Norte | Hospital Santa Maria - Rheumatology Department
🇵🇹Lisboa, Portugal
Centro Reumatologico de Caguas | Caguas, PR
🇵🇷Caguas, Puerto Rico
GCM Medical Group, PSC | San Juan, PR
🇵🇷San Juan, Puerto Rico
Hospital Universitario de Badajoz
🇪🇸Merida, Badajoz, Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
🇪🇸Sabadell, Barcelona, Spain
Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
National Cheng Kung University
🇨🇳Tainan, Tainan City, Taiwan
National Taiwan University Hospital
🇨🇳Zhong Zheng Qu, Taipei City, Taiwan
Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department
🇨🇳New Taipei City, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Chi Mei Medical Center
🇨🇳Tainan City, Taiwan