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)
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24 — Week 24 Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes.
Trial sites (2)
Facility
City
Region
Status
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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