RecruitingPsoriasis (PsO)EnthesitisPsoriasis Arthritis
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)
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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)
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
You may qualify if…
- ✓ 1. Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis
- ✓ 2. Meet one of the following conditions: Psoriasis Area and Severity Index \[PASI\] score \> 6, or scalp involvement, or nail involvement.
- ✓ 3. 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
- ✓ 4. Psoriasis is inadequately controlled by current topical therapy or phototherapy
- ✓ 5. Able to sign the informed consent
You may not qualify if…
- ✕ 1. Diagnosis of PsA2 according to CASPAR
- ✕ 2. Any known rheumatic disease, positive rheumatoid factor/anti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs
- ✕ 3. Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
- ✕ 4. Obesity impeded ultrasound examination
- ✕ 5. Pregnant or lactating women or women with plan for conception 5 months before or after treatment
- ✕ 6. Participated in other clinical trials
- ✕ 7. Concurrent significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg), congestive heart failure (NYHA class III or IV), total white blood cell count \< 2500/μl, or platelets \< 100,000/μl or neutrophils \< 1500/μl or hemoglobin \< 8.5 g/dL at screening.
- ✕ 8. Any liver function abnormality: aspartate aminotransferase (AST) \> 2xULN, alanine aminotransferase (ALT) \> 2xULN, total bilirubin (TBIL) \> 2xULN
Source: ClinicalTrials.gov · NCT06987292 · last updated 2025-05-23