About this trial
It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)
Eligibility criteria
Qualifiers
Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis
Meet one of the following conditions: Psoriasis Area and Severity Index [PASI] score > 6, or scalp involvement, or nail involvement.
Inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point at screening, defined as thickening and/or abnormal echogenicity of tendons or ligaments at the site of their insertion into the bone (within 2 mm of the talar cortex), and active Doppler signals that may indicate structural damage such as bone erosion, syndesmophytes/calcifications
Psoriasis is inadequately controlled by current topical therapy or phototherapy
Disqualifiers
Diagnosis of PsA2 according to CASPAR
Any known rheumatic disease, positive rheumatoid factor/anti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs
Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
Obesity impeded ultrasound examination
Trial design
Treatments tested in this trial
- IL-17i