A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
ConditionPsoriatic Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
The participant has a diagnosis of PsA.
The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Zasocitinib
DrugZasocitinib over-encapsulated tablets.
Active Comparator
DrugActive comparator capsule.
Placebo
DrugZasocitinib or active comparator matching placebo.
Treatment groups
1,088 Participants
are divided into 4 treatment groupsGroup A: Zasocitinib Dose AExperimental treatment 1 intervention
Group B: Zasocitinib Dose BExperimental treatment 1 intervention
Group C: Active Comparator Dose CActive comparator 1 intervention
Group D: Placebo + ZasoctinibExperimental treatment 2 interventions
Trial outcomes
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 16Secondary 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 162
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 163
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 164
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 Source ClinicalTrials.gov