CClinicalTrials.gg
RecruitingNCT06671496Updated Sep 9, 2026

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

A Phase 3 interventional study of Zasocitinib and Placebo in Psoriatic Arthritis, sponsored by Takeda. Recruiting at 123 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 based on their previous experience with specific treatments.

The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.

02

Conditions studied

  • Psoriatic Arthritis

Browse trials for

Keywords

  • Drug Therapy
  • Latitude Research Program
  • Latitude PsA
  • Latitude PsA-3002
03

In context

Arthritis, Psoriatic

579 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.

This study's planned enrollment of 600 is above the median of 135 across 322 interventional studies indexed under Arthritis, Psoriatic.

Browse Arthritis, Psoriatic studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Age:

  1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).

    Disease Characteristics:

  2. The participant has a diagnosis of PsA.
  3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
  4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
  5. The participant has active arthritis as shown by a minimum of >=3 tender joints in TJC68 and >=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
  6. The participant has at least 1 active lesion of plaque PsO >=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.

    Medications for PsA:

  7. The participant has had at least one of the following:

    1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union [EU]/ European Economic Area [EEA]), OR
    2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
    3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.

Exclusion criteria

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Zasocitinib Dose A

    Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.

    Drug: Zasocitinib

  • Experimental
    Zasocitinib Dose B

    Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.

    Drug: Zasocitinib

  • Experimental
    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 · Drug: Placebo

Interventions

  • DrugZasocitinib

    Zasocitinib tablets.

    Also known as: TAK- 279, NDI-034858

  • DrugPlacebo

    Zasocitinib matching placebo.

06

What researchers measure

Primary outcomes

  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.

    Time frame: At Week 16

Secondary outcomes

  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.

    Time frame: At Week 16

  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.

    Time frame: Baseline, at Week 16

  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.

    Time frame: At Week 16

  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.

    Time frame: Baseline, at Week 16

  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.

    Time frame: At Week 16

  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.

    Time frame: Baseline, at Week 16

  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.

    Time frame: Baseline, at Week 16

  8. Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The LEI is defined as a 6-item ClinRO measure specifically developed for PsA. It assesses the presence or absence of pain/tenderness when 4 kilograms per centimeter square (kg/cm\^2) of pressure is applied to 6 enthesial sites: the lateral epicondyles, medial femoral condyles, and Achilles tendon insertions on both sides of the body. Tenderness at each site is recorded on a dichotomous scale (0 = non-tender, 1 = tender). The total score is the sum of tender sites, ranging from 0 to 6, with a higher score indicating a greater enthesitis burden. Percentage of participants achieving LEI =0 (in participants with a baseline LEI \>=1) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  9. Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR response is defined as: improvement from baseline in both SJC66 and TJC68, and improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain (0-100 visual analogue scale \[VAS\]); PtGA of PsA (0-100 VAS); PGA of PsA (0-100 VAS); participant's assessment of physical function as measured by HAQ-DI (0-3 scale); hsCRP. Change from baseline in individual components of ACR response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  10. Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The LDI is defined as a ClinRO measure use to assess the presence of dactylitis. It involves measuring the circumference of all 20 digits using a dactylometer, with measurements taken around the proximal phalanx as close to the web space as possible. Moderate pressure is applied to assess tenderness or pain in the affected digits. Tenderness is scored on a binary scale (0 = non-tender, 1 = tender). Only digits with a circumference ratio exceeding 10% are considered to have dactylitis. A higher score indicates worse dactylitis. Percentage of participants achieving LDI =0 (in participants with a baseline LDI \>=1) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  11. Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 4 and 8 for Zasocitinib Dose A and B Compared to Placebo

    A PASI-75 response is defined as \>=75% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-75 response (in participants with a baseline \>=3% BSA) at Week 8 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 4 and 8

  12. Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    A PASI-90 response is defined as \>=90% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-90 response (in participants with a baseline \>=3% BSA) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  13. Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    A PASI-100 response is defined as \>=100% improvement in the PASI score from baseline. It is a ClinRO used to measure psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating no involvement and 4 indicating very marked involvement. PASI scores range from 0 to 72, with \<=3 representing mild disease, \>=3 to 15 representing moderate disease, and \>=15 indicating severe disease. Percentage of participants achieving PASI-100 response (in participants with a baseline \>=3% BSA) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  14. Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    ACR responses measure improvement in multiple criteria, a composite COA with ClinROs and PROs. An ACR50 response is \>=50% improvement in SJC66 and TJC68, and 3 of 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA, HAQ-DI, hsCRP. A PASI-100 response is \>=100% improvement in the PASI score from baseline. It's a ClinRO measuring psoriasis severity, combining the percent of affected skin surface area with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored from 0 (no involvement) to 4 (very marked involvement). PASI scores range from 0 to 72, with \<=3 as mild, \>=3 to 15 as moderate, and \>=15 as severe disease. Percentage of participants achieving ACR50 and PASI-100 response (in participants with a baseline \>=3% BSA) simultaneously at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  15. Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    Static physician's global assessment (sPGA) is defined as a 5-point ClinRO measure used to assess the current state of psoriasis based on severity of erythema, induration, and scaling. The total sPGA score ranges from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe, with higher scores indicating greater disease severity. Each lesion characteristic (erythema, induration, and scaling) is graded separately on a 5-point scale: erythema (0 = no evidence to 4 = bright red coloration), induration (0 = no evidence to 4 = severe plaque elevation), and scaling (0 = no evidence to 4 = thick scaling). Lesion scores for erythema, induration, and scaling are averaged and rounded to nearest whole number to compute total score. Percentage of participants achieving sPGA response of clear (0) or almost clear (1) with \>=2-point decrease from baseline (in participants with a baseline sPGA \>=2) at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  16. Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The HAQ-DI is defined as a 20-item PRO measure used to assess functional ability over the past week across 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each category includes 2-3 activities rated on a 4-point scale (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). Assistive devices and personal assistance are also noted. The HAQ-DI score is calculated as the mean of the category scores (0 = no disability, 3 = completely disabled), with scores of 0-1 indicating mild-to-moderate disability, 1-2 moderate-to-severe, and 2-3 severe-to-very severe disability. Participants must have scores for at least 6 categories for the HAQ-DI to be computed. Percentage of responders achieving minimal clinically important differences (reduction of \>=0.35 from baseline) in HAQ-DI score from baseline at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  17. Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 MCS score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  18. Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The PsAID-12 is defined as a 12-item PRO measure that assesses symptoms such as pain, fatigue, and skin problems and the impact of PsA on the participant's life over the past week. It covers areas including work and/or leisure activities, physical activities, sleep, anxiety, embarrassment or shame, social participation, and depression. The response options are rated on a numerical rating scale (NRS) from 0 (none/no difficulty) to 10 (extreme difficulty), with higher scores indicating a greater impact of the disease. Change from baseline in PsAID-12 total score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  19. Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The DAPSA is defined as a composite measure of peripheral joint disease activity that includes ClinROs, PROs, and a laboratory test. DAPSA is calculated as the sum of the following components: tender joint count (0-68), swollen joint count (0-66), hsCRP level (milligrams per deciliter \[mg/dL\]), PtGA of PsA pain (0-100 VAS), and PtGA of PsA (0-100 VAS). DAPSA cutoffs for disease activity are: remission (\<=4), low disease activity (\>4 to \<=14), moderate disease activity (\>14 to \<=28), and high disease activity (\>28). Change from baseline in DAPSA score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  20. Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The DAS28 with high-sensitivity C-reactive protein is defined as a derived index combining the tender joint count (28 joints), swollen joint count (28 joints), hsCRP, and PtGA of PsA. The 28-joint count includes the shoulder, elbow, wrist, metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5 of both upper extremities, and the knee joints of both lower extremities. The DAS28 score ranges from 0 to 10, with higher scores indicating greater disease activity. Change from baseline in DAS28 C-reactive protein score at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  21. Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The PGA-F is defined as a ClinRO measure assessing the severity of fingernail PsO. It evaluates nail bed signs (onycholysis, hyperkeratosis, erythema, splinter hemorrhages) and nail matrix signs (pitting, ridging, discoloration). Clinicians rate the severity using categories: clear (0), minimal (1), mild (2), moderate (3), and severe (4). The total score is based on the area with the most involvement (nail bed or matrix), ranging from 0 (clear) to 4 (very severe), with higher scores indicating more severe fingernail PsO. Change from baseline in PGA-F score in participants with PGA-F \>0 from baseline at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  22. Percentage of Participants Achieving a Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesis Index = 0 through Week 16 for Zasocitinib Dose A and B Compared to Placebo

    The SPARCC Enthesis Index is a ClinRO measure that assesses the presence or absence of pain/tenderness when 4 kg/cm\^2 of pressure is applied to 18 enthesial sites across the following 9 bilateral sites: Achilles tendons, plantar fascia insertion at the calcaneus, greater tuberosity of the humerus, medial epicondyles, lateral epicondyles, greater trochanter, quadriceps insertion, inferior patella, and tibial tuberosity. Tenderness at each site is recorded as either present (1) or absent (0). Total score is the sum of score from each site, ranging from 0 to 16, with higher scores indicating greater enthesis burden. Percentage of participants achieving a SPARCC Enthesis Index = 0 through Week 16 for zasocitinib Dose A and B compared to placebo will be reported

    Time frame: Baseline up to Week 16

  23. Percentage of Participants Achieving ACR20 Response at Week 8 for Zasocitinib Dose A and B Compared to Placebo

    ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs and PROs. An ACR20 response is defined as: \>= 20% improvement from baseline in both SJC66 and TJC68, and \>=20% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP. Percentage of participants achieving ACR20 response at Week 8 for zasocitinib Dose A and B compared to placebo will be reported.

    Time frame: At Week 8

  24. Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo

    The SF-36 v2.0 is defined as a self-administered, validated questionnaire designed to measure general health-related quality of life (QoL). This 36-item questionnaire measures 8 domains over the past 4 weeks, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Summary score PCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. Change from baseline in the SF-36 v2.0 PCS score at Week 16 for zasocitinib Dose B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

  25. Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo

    The FACIT-fatigue score is defined as a 13-item PRO measure that assesses the severity of self-reported fatigue and its impact on daily functioning over the past 7 days. It includes items measuring tiredness, weakness, listlessness, lack of energy, and the effects on activities such as sleep and social interactions. Each item is rated on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The total score ranges from 0 to 52, with higher scores indicating less fatigue. Change from baseline in the FACIT- fatigue score at Week 16 for zasocitinib Dose B compared to placebo will be reported.

    Time frame: Baseline, at Week 16

07

Study locations

118 of 123 sites recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Mesa, Arizona 85210, United States
    Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Phoenix, Arizona 85032, United States
    Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Tucson, Arizona 85748, United States
    Recruiting
  • Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
    Covina, California 91722, United States
    Recruiting
  • RASF- Clinical Research Center
    Boca Raton, Florida 33486-1390, United States
    • Site Contact · Contact · sbb61@aol.com · 5651-361-6547
    • Shawn Baca · Principal investigator
    Recruiting
  • Direct Helpers Medical Center
    Hialeah, Florida 33012, United States
    Recruiting
  • IRIS Research and Development | Plantation, FL
    Plantation, Florida 33324, United States
    Recruiting
  • BayCare Medical Group
    St. Petersburg, Florida 33705, United States
    Recruiting
  • North Georgia Rheumatology Group PC
    Lawrenceville, Georgia 30046, United States
    • Site Contact · Contact · tolfmd@aol.com
    • Theresa Lawrence Ford · Principal investigator
    Recruiting
  • Clinic of Robert Hozman
    Skokie, Illinois 60076, United States
    Completed
  • Graves Gilbert Clinic
    Bowling Green, Kentucky 42101, United States
    • Site Contact · Contact · frasera@ggclinic.com · 270-781-5111
    • Asad Fraser · Principal investigator
    Recruiting
  • Johns Hopkins Hospital
    Baltimore, Maryland 21205, United States
    • Site Contact · Contact · aorbai1@jhmi.edu · 410-550-8089
    • Ana-Maria Orbai · Principal investigator
    Recruiting
  • Advanced Rheumatology PC | Lansing, MI
    Lansing, Michigan 48910-5894, United States
    Recruiting
  • AARR- Kansas City Physician Partners
    Kansas City, Missouri 85032, United States
    Recruiting
  • DJL Clinical Research | Charlotte, NC
    Charlotte, North Carolina 28210, United States
    Recruiting
  • University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
    Cleveland, Ohio 44106, United States
    Recruiting
  • Paramount Medical Research & Consulting, LLC
    Middleburg Heights, Ohio 44130, United States
    • Site Contact · Contact · idiabmd@gmail.com · 440-826-0742
    • Isam Diab · Principal investigator
    Recruiting
  • Altoona Center for Clinical Research | Ducansville, PA
    Duncansville, Pennsylvania 16635, United States
    Recruiting
  • AARR- Lone Star Arthritis & Rheumatology Associates
    Fort Worth, Texas 76109, United States
    Recruiting
  • Biopharma Informatic | Hassan
    Houston, Texas 77089, United States
    Recruiting
  • Advanced Rheumatology of Houston - The Woodlands
    The Woodlands, Texas 77382, United States
    • Site Contact · Contact · tbrionez@gmail.com · 281-766-7886
    • Tamar Brionez · Principal investigator
    Recruiting
  • Swedish Rheumatology Research
    Seattle, Washington 98122, United States
    Recruiting
  • Instituto de Investigaciones Clinicas Quilmes
    Quilmes, Buenos Aires B1878, Argentina
    Recruiting
  • Clinica Regional del Sud S.A.
    Río Cuarto, Córdoba Province X5804GAO, Argentina
    • Site Contact · Contact · nanmaldonado@msn.com · 54 (0) 358-4679500
    • Hernan Maldonado Ficco · Principal investigator
    Recruiting
  • Centro de Investigaciones Reumatologicas
    San Miguel de Tucumán, Tucumán Province 4000, Argentina
    Recruiting
  • CIMER
    San Miguel de Tucumán, Tucumán Province T4000, Argentina
    Recruiting
  • Hospital General de Agudo Jose Maria Ramos Mejia
    Buenos Aires, C1221ADC, Argentina
    Withdrawn
  • APRILLUS Asistencia e Investigacion Clinica
    Buenos Aires, C1406AGA, Argentina
    Recruiting
  • Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina
    Córdoba, X5000, Argentina
    Recruiting
  • CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
    San Juan, 5400, Argentina
    Recruiting
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales NSW 2050, Australia
    Recruiting
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
    Recruiting
  • Sunshine Coast University Private Hospital | Clinical Trials
    Sippy Downs, Queensland QLD 4575, Australia
    Recruiting
  • The Queen Elizabeth Hospital | Rheumatology Department
    Woodville South, South Australia SA 5011, Australia
    Recruiting
  • Fiona Stanley Hospital
    Palmyra Dc, Western Australia 6961, Australia
    Recruiting
  • Colin Bayliss Research and Teaching Unit
    Victoria Park, Western Australia WA 6100, Australia
    • Site Contact · Contact · robw@bdaus.com.au · 61894721904
    • Robert Will · Principal investigator
    Recruiting
  • CMIP-Centro Mineiro de Pesquisa Ltda
    Juiz de Fora, Minas Gerais 36010-570, Brazil
    Recruiting
  • Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
    Uberlândia, Minas Gerais 38405-320, Brazil
    Recruiting
  • EDUMED - Educacao em Saude SS Ltda
    Curitiba, Paraná 80440-210, Brazil
    Recruiting
  • LMK Servicos Medicos Sociedade Simples
    Porto Alegre, Rio Grande do Sul 90480-000, Brazil
    Recruiting
  • Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department
    São José do Rio Preto, São Paulo 15090-000, Brazil
    Recruiting
  • CEPIC - Centro Paulista de Investigacao Clinica
    São Paulo, 04266-010, Brazil
    Recruiting
  • Niagara Rheumatology Research Centre | Ontario, Canada
    Niagara Falls, Ontario L2E 6A6, Canada
    • Site Contact · Contact · rdhillon96@gmail.com · 289-296-6194
    • Rajwinder Dhillon · Principal investigator
    Recruiting
  • University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases
    Toronto, Ontario M5T 2S8, Canada
    Withdrawn
  • G.R.M.O. Inc.
    Québec, Quebec G1V 3M7, Canada
    Recruiting
  • The First Affiliated Hospital Of Bengbu Medical College
    Bengbu, Anhui 233004, China
    • Site Contact · Contact · uglboy2002@126.com · 15255227208
    • Changhao Xie · Principal investigator
    Recruiting
  • Xuanwu Hospital Capital Medical University
    Beijing, Beijing Municipality 100053, China
    Recruiting
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
    • Site Contact · Contact · murongster@163.com · 13501170870
    • Rong Mu · Principal investigator
    Recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
    • Site Contact · Contact · zengxfpumc@163.com · 13501069845
    • Xiaofeng Zeng · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian 361003, China
    • Site Contact · Contact · gshi@xmu.edu.cn · 86 13600932661
    • Guixiu Shi · Principal investigator
    Recruiting
  • Guangzhou First People's Hospital
    Guangzhou, Guandong 519180, China
    • Site Contact · Contact · 13503080061@126.com · 13503080061
    • Xiaoyan Cai · Principal investigator
    Recruiting
  • Shenzhen People's Hospital
    Shenzhen, Guangdong 518020, China
    • Site Contact · Contact · liu_dz2001@sina.com · 13802257360
    • Dongzhou Liu · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 471000, China
    • Site Contact · Contact · sxf64817332@163.com · 13663884080
    • Xiaofei Shi · Principal investigator
    Recruiting
  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
    Wuhan, Hubei 430022, China
    • Site Contact · Contact · huyu1964@tom.com · 13995671635
    • Qiubai Li · Principal investigator
    Recruiting
  • Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
    Zhuzhou, Hunan 412007, China
    • Site Contact · Contact · zzyyy888@126.com · 13007452129
    • Jing-yang Li · Principal investigator
    Recruiting
  • Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital
    Baotou Shi, Inner Mongolia 014010, China
    Recruiting
  • The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)
    Hangzhou, Jiangsu 215005, China
    • Site Contact · Contact · wuumin@163.com
    • Min Wu · Principal investigator
    Recruiting
  • Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
    Nanjing, Jiangsu 210029, China
    • Site Contact · Contact · fenny.ok@163.com · 13814091488
    • Yao Ke · Principal investigator
    Recruiting
  • Affiliated Hospital of Nantong University
    Nantong, Jiangsu 226001, China
    • Site Contact · Contact · dazhanyun@163.com · 13962995350
    • Zhanyun Da · Principal investigator
    Recruiting
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu 225007, China
    Recruiting
  • Jiujiang No.1 People's Hospital
    Jiujiang Shi, Jiangxi 332000, China
    • Site Contact · Contact · jjliuju@163.com · 13807028296
    • Ju Liu · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    • Site Contact · Contact · tcmclinic@163.com · 13970997559
    • Rui Wu · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330008, China
    • Site Contact · Contact · 13970085678@163.com · 13970085678
    • Xin-Wang Duan · Principal investigator
    Recruiting
  • Jiangxi Pingxiang People's Hospital
    Pingxiang, Pingxiang Pingxiang, China
    • Site Contact · Contact · hjk0799@163.com · 13879936380
    • Jiankang Hu · Principal investigator
    Recruiting
  • The 2nd Hospital of Xi'An Jiaotong University
    Xi'an, Shan'xi 710004, China
    • Site Contact · Contact · 13992891987@139.com · 13811038669
    • Xueyi Li · Principal investigator
    Recruiting
  • Linyi People's Hospital
    Linyi Shi, Shandong 276000, China
    Recruiting
  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    Pudong New District, Shanghai Municipality 200127, China
    • Site Contact · Contact · leeting007@163.com · 13916927066
    • Ting Li · Principal investigator
    Recruiting
  • First Hospital of Shanxi Medical University
    Taiyuan, Shanxi 030001, China
    • Site Contact · Contact · fuzili72@163.com · 86 13834676095
    • Zili Fu · Principal investigator
    Recruiting
  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
    Taiyuan, Shanxi 030605, China
    • Site Contact · Contact · 1315710223@qq.com · 13834537708
    • Li-yun Zhang · Principal investigator
    Recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
    • Site Contact · Contact · yi2006liu@163.com · 13386277602
    • Yi Liu · Principal investigator
    Recruiting
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
    Chengdu, 610072, China
    Recruiting
  • Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)
    Guangzhou, 510630, China
    • Site Contact · Contact · gujieruo@163.com · 13922280820
    • Jie-ruo Gu · Principal investigator
    Recruiting
  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
    Shanghai, 200052, China
    • Site Contact · Contact · hbs1976@126.com
    • Ting Jiang · Principal investigator
    Recruiting
  • Wenzhou Medical University (WMU) - The First Affiliated Hospital
    Wenzhou, 325000, China
    Recruiting
  • Clinique de l'Infirmerie Protestante
    Caluire-et-Cuire, Auvergne-Rhône-Alpes 69300, France
    Recruiting
  • CHU Toulouse
    Toulouse, Haute Garonne 31059, France
    Recruiting
  • CHRU de Tours
    Tours, Indre Et Loire 37044, France
    Recruiting
  • CHU de Reims
    Reims, Marne " 51100", France
    • Site Contact · Contact · jhsalmon@chu-reims.fr · 33661551155
    • Jean-Hugues Salmon · Principal investigator
    Recruiting
  • Hopital Nord
    Saint-Etienne, 13015, France
    Recruiting
  • Universitatsklinikum Leipzig
    Leipzig, Saxony 4103, Germany
    Recruiting
  • Private Practice - Dr. Maren Sieburg
    Magdeburg, Saxony-Anhalt 39104, Germany
    Completed
  • ISA - Interdisciplinary Study Association
    Berlin, 10789, Germany
    Recruiting
  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
    Hamburg, 20095, Germany
    • Site Contact · Contact · everding@hotmail.de · 49(0)43-31-33-76-60
    • Andrea Everding · Principal investigator
    Recruiting
  • Rheumazentrum Ruhrgebiet
    Herne, 44649, Germany
    Recruiting
  • Kojunkai Social Medical Corporation Daido Clinic
    Minami-ku, Nagoya-shi, Aichi-ken 457-8511, Japan
    Recruiting
  • Nagoya City University Hospital
    Nagoya, Aichi-ken 467-8602, Japan
    Recruiting
  • Hokkaido University Hospital
    Sapporo, Hokkaido 060-8648, Japan
    Recruiting
  • Fukuoka University Hospital
    Fukuoka, Hukuoka 814-0180, Japan
    Recruiting
  • Kita-Harima Medical Center
    Ono-shi, Hyōgo 675-1392, Japan
    Recruiting
  • Mie University Hospital
    Tsu, Mie, Mie-ken 514-8507, Japan
    • Site Contact · Contact · keiichiyamanaka@me.com · 81 (0) 59-231-5025
    • Keiichi Yamanaka · Principal investigator
    Recruiting
  • National University Corporation Tohoku University Tohoku University Hospital
    Sendai, Miyagi 980-8574, Japan
    Recruiting
  • Tohoku Medical and Pharmaceutical University Hospital
    Sendai, Miyagi 983-8512, Japan
    Recruiting
  • Sasebo Chuo Hospital
    Sasebo-shi, Nagasaki 857-1195, Japan
    Recruiting
  • Nippon Life Hospital
    Nishi Ward, Osaka 550-0006, Japan
    Recruiting
  • St. Luke's International Hospital
    Chuo-ku, Tokyo 104-8560, Japan
    Recruiting
  • National Hospital Organization Tokyo Medical Center
    Meguro-Ku, Tokyo 152-8902, Japan
    Recruiting
  • Toho University Ohashi Medical Center
    Meguro-ku, Tokyo 153-8515, Japan
    Recruiting
  • Tokyo Medical University Hospital
    Shinjuku-Ku, Tokyo 160-0023, Japan
    Recruiting
  • Kyorin University Hospital
    Mitaka-shi, Tokyo-To 181-8611, Japan
    • Site Contact · Contact · kishimotomi@gmail.com · 81 (0) 3-3541-5151
    • Mitsumasa Kishimoto · Principal investigator
    Recruiting
  • MICS Centrum Medyczne Bydgoszcz
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-090, Poland
    Recruiting

Showing the first 100 of 123 sites across 12 countries.

08

References and documents

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06671496
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Nov 4, 2024
Start date
Mar 10, 2025
Primary completion
May 18, 2027 (estimated)
Completion
Jan 26, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Takeda Contact
Contact
medinfoUS@takeda.com
+1-877-825-3327
Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion