GUSELKUMAB for Psoriatic arthritis|Psoriasis

Inclusion criteria

• {"criterion_text":"-Adult ≥ 18 years of age."}
• {"criterion_text":"-Subject must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent."}
• {"criterion_text":"-Subjects are willing and able to comply with procedures required in this protocol."}
• {"criterion_text":"-Presence of current from moderate to severe skin psoriasis (PASI≥10) or mild psoriasis (PASI≤10) with the involvement of sensitive area (face, palms, soles, nails, and genital area) diagnosed by a dermatologist with experience in the management of psoriatic disease."}
• {"criterion_text":"-Absence of clinical signs of active arthritis, dactylitis, enthesitis and inflammatory back pain at enrolment."}
• {"criterion_text":"-Absence of systemic treatment for psoriasis (csDMARDs and/or bDMARDs and/or tsDMARDs treatment) in the last 6 months."}
• {"criterion_text":"-The presence of peripheral arthralgia clinically suspected for subclinical PsA (definition in Appendix A)"}
• {"criterion_text":"-The Presence of at least 2 out of the following 4 sonographic lesions of subclinical inflammation or structural damage suspicious for a psoriatic musculoskeletal inflammation: (i) articular synovitis GS≥ 2 in at least 2 joints; (ii) tenosynovitis GS≥ 1 in at least 2 sites; (iii) active enthesitis in at least one site; (iv) entheseal erosion in at least one site. Ultrasound findings suggestive of subclinical PsA shall be submitted for centralized assessment and independently reviewed by two readers Sonographic Analysis Protocol  The sonographic examination will preferably be performed on the same day as the clinical assessment; however, a delay of up to 72 hours from the clinical evaluation will be tolerated. The ultrasound assessment will be conducted blinded to the clinical examination and focused in a longitudinal and transverse scan of 42 regions encompassing the following: metacarpophalangeal, proximal and distal interphalangeal joints of the hands, wrists, knees, metatarsophalangeal joints, 12 entheses (Achilles, quadriceps, proximal and distal patellar, plantar aponeurosis and common extensor tendon entheses), the 2 retro-calcaneal bursae and 32 tendons (extensor digitorum tendons of the hands, flexor digitorum tendons of the hands and extensor tendon compartments of the wrist). The sites to be scanned and sonographic definitions of the lesions (i.e., synovitis, tenosynovitis, enthesitis, peritenon extensor tendon inflammation and bursitis) and damage lesions (i.e., joint erosions, entheseal erosions, enthesophytes and articular osteoproliferation) will be defined according to the OMERACT and EULAR definitions (Appendix B)."}

Exclusion criteria

• {"criterion_text":"-Contraindication to start a new bDMARD treatment course."}
• {"criterion_text":"-Fulfilment of CASPAR criteria for PsA."}
• {"criterion_text":"-Subjects with a history of cancer within the past 5 years, as well as those with any current or suspected malignancy at the time of enrollment."}
• {"criterion_text":"-Known hypersensitivity or allergy to Guselkumab or to any component of the investigational medicinal product, including excipients."}
• {"criterion_text":"-Treatment with systemic treatment (csDMARDs or bDMARDs or tsDMARDs) and steroid injection in the 6 months previous enrolment."}
• {"criterion_text":"-Has previously received treatment with an IL-23 inhibitor"}
• {"criterion_text":"-Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent;"}
• {"criterion_text":"-For women of childbearing potential*: pregnancy status, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after study completion; *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy."}
• {"criterion_text":"-Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient;"}
• {"criterion_text":"-Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections;Note: Subjects with a recent acute infection may be enrolled only after full clinical resolution of all signs and symptoms for at least 4 weeks prior to screening."}
• {"criterion_text":"-Previous or current diagnosis of PsA."}
• {"criterion_text":"-Presence of swollen joints, dactylitis or at clinical examination."}

Primary endpoints

• {"endpoint_text":"-The percentage of patients with subclinical PsA who achieve resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) together with the effect of guselkumab on objectively quantified synovio-entheseal inflammation, as co-primary objective endpoint evaluated using the UPsA activity activity Score [Timepoint: Week 24].","definition_or_measurement_approach":"Resolution of arthralgia defined as VAS pain ≤ 1/10 and TJC ≤ 1/10; synovio-entheseal inflammation measured using the UPsA Activity Score; timepoint Week 24."}

Secondary endpoints

• {"endpoint_text":"-\tThe change of the synovio-entheseal inflammation score detected by US at w24 and w52","definition_or_measurement_approach":"Measured by ultrasound (US) using the defined sonographic scoring system at Week 24 and Week 52."}
• {"endpoint_text":"-\tThe incidence of progression to PsA (defined as CASPAR criteria fulfilment) at w52","definition_or_measurement_approach":"Progression defined as fulfillment of CASPAR criteria; assessed at Week 52."}
• {"endpoint_text":"-\tThe percentage of patients who achieved clinical resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) at w52","definition_or_measurement_approach":"Clinical resolution per VAS pain ≤1/10 and TJC ≤1/10 assessed at Week 52."}
• {"endpoint_text":"-\tThe percentage of patients who achieve PASI 100 at w24 and w52","definition_or_measurement_approach":"PASI 100 (100% improvement in Psoriasis Area and Severity Index) assessed at Week 24 and Week 52."}
• {"endpoint_text":"-\tThe change of the Patient Reported Outcomes (e.g. HAQ, BASDAI, DLQI, PsAID).","definition_or_measurement_approach":"Changes measured using patient-reported outcome instruments such as HAQ, BASDAI, DLQI, PsAID at specified visits."}
• {"endpoint_text":"-\tChange in total modified Sharp–van der Heijde (mSvH) score from baseline to Week 52, including erosion score and joint space narrowing components.","definition_or_measurement_approach":"Radiographic change measured by modified Sharp–van der Heijde (mSvH) scoring from baseline to Week 52, including erosion and joint space narrowing components."}

Italy

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

8

Number Of Sites

4

Number Of Participants

90

Primary sponsor

Full Name

Azienda Sanitaria Universitaria Friuli Centrale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy