Actively Recruiting
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)
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-05-23
50
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥ 18 years of age) with chronic plaque-type psoriasis
- Psoriasis Area and Severity Index (PASI) score greater than 6, or scalp involvement, or nail involvement
- Inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point at screening
- Psoriasis inadequately controlled by current topical therapy or phototherapy
- Able to sign the informed consent
You will not qualify if you...
- Diagnosis of Psoriatic Arthritis according to CASPAR criteria
- Any known rheumatic disease or prior treatment with anti-rheumatic drugs
- Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
- Obesity that impedes ultrasound examination
- Pregnant or lactating women or women planning conception 5 months before or after treatment
- Participation in other clinical trials
- Uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 95 mmHg), congestive heart failure (NYHA class III or IV), or abnormal blood counts at screening
- Liver function abnormalities (AST > 2xULN, ALT > 2xULN, total bilirubin > 2xULN)
- Abnormal renal function with serum creatinine > 2.0 mg/dl
- History or evidence of tuberculosis infection
- Current or past HIV, hepatitis B or C infection
- History of lymphoproliferative disease or malignancy within past 5 years
- Unable or unwilling to undergo repeated blood draws
- History of alcohol or drug abuse within 6 months prior to baseline
- History of hypersensitivity to any component of the study drug
- Did not accept live vaccines within 4 weeks prior to enrollment and no live vaccines planned during study or 6 months after last dose (herpes zoster vaccine > 12 months)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
2
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
W
Wenjun Hou, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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