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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522586-30-00 | EU Trial (CTIS) Number |
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Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.
The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.
Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).
Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zasocitinib Dose A or Dose B | Experimental | Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104. |
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| Re-randomized Participants - Zasocitinib Dose A or Dose B | Experimental | Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 [NCT06671483]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zasocitinib | Drug | Zasocitinib oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any AE emerging or manifesting at or after the initiation of treatment in the LTE study with a trial intervention or medicinal product or any existing AE that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. | From start of study drug administration up to follow-up (up to Week 108) |
| Number of Participants With Adverse Events of Special Interest (AESI) | An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate. | From start of study drug administration up to follow-up (up to Week 108) |
| Number of Participants With Clinically Significant Changes in Vital Sign Values | Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion. | From start of study drug administration up to follow-up (up to Week 108) |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Values | Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology (ACR20) Response at Weeks 24, 48, and 104 | 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 percentage (%) 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 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology Research Inc. | Recruiting | Fountain Valley | California | 92708 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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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.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| From start of study drug administration up to follow-up (up to Week 108) |
| At Weeks 24, 48, and 104 |
| Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104 | 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. | At Weeks 24, 48, and 104 |
| Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104 | 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. | At Weeks 24, 48, and 104 |
| Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104 | 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 (PsO) <=3%, PtGA of PsA Pain score <=15, PtGA of PsA score <=20, HAQ-DI <=0.5, and Leeds Enthesitis Index (LEI) <=1. | At Weeks 24, 48, and 104 |
| Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104 | A PASI-75 response is defined as >=75% improvement in the PASI score from baseline. It is a ClinRO used to measure PsO severity, combining the percentage of surface area of skin affected 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 a complete lack of cutaneous involvement and 4 indicating the severest possible involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease. | At Weeks 24, 48, and 104 |
| The Cohen Medical Centers | Recruiting | Thousand Oaks | California | 91360-3967 | United States |
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| Denver Arthritis Clinic - Lowry | Recruiting | Denver | Colorado | 80230 | United States |
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| Direct Helpers Research Center | Recruiting | Hialeah | Florida | 33012 | United States |
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| IRIS Research and Development | Recruiting | Plantation | Florida | 33324 | United States |
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| Klein and Associates, M.D., P.A. | Recruiting | Hagerstown | Maryland | 21740-6138 | United States |
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| Paramount Medical Research & Consulting, LLC | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
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| West Tennessee Research Institute | Recruiting | Jackson | Tennessee | 38305 | United States |
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| Accurate Clinical Research | Recruiting | Baytown | Texas | 77521 | United States |
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| Novel Research LLC | Recruiting | Bellaire | Texas | 77401 | United States |
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| Northwest Houston Arthritis Center | Recruiting | Houston | Texas | 77090 | United States |
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| West Texas Clinical Research | Recruiting | Lubbock | Texas | 79424 | United States |
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| Mie University Hospital | Recruiting | Tsu, Mie | Mie-ken | 514-8507 | Japan |
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| St. Luke's International Hospital | Recruiting | Chuo-ku | Tokyo | 104-8560 | Japan |
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| National Hospital Organization Tokyo Medical Center | Recruiting | Meguro-Ku | Tokyo | 152-8902 | Japan |
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| Centro Reumatologico de Caguas | Recruiting | Caguas | 00725 | Puerto Rico |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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