TrialPath
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)

NCT06987292 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS): a Single-center, Prospective, Exploratory, Open-label Study
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)
Eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 9. Abnormal renal function: serum creatinine \> 2.0 mg/dl 10. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection, defined as a positive PPD skin test or Mycobacterium tuberculosis interferon-gamma release assay (IGRA) test. 11. Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. 12. History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years 13. Unable or unwilling to undergo repeated venipuncture 14. History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline 15. History of hypersensitivity to any component of the study drug 16. Did not accept live vaccines within 4 weeks prior to enrollment, do not have plan of vaccination program during the study, and no live vaccines are planned \> 6 months after the last dose of the study (herpes zoster vaccine \> 12 months)
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-01
Estimated completion: 2027-12-31
Last updated: 2025-05-23
Interventions
Drug: IL-17i
Primary outcomes
  • Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24 (Week 24)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · other
Contacts & investigators
ContactWenjun Hou, Dr · contact · hwjnanjing@126.com · + 86 135 8402 3320
All locations (2)
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, Jiangsu, China
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, Jiangsu, China
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) · TrialPath