A Prospective Study to Assess the Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

2
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School210008, NanjingJiangsu, China
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School210008, NanjingJiangsu, China

Sponsors and collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor