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)

Официальное название

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

Обзор

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)

Вмешательства

• Препарат IL-17i
  IL-17 inhibitors

Первичные конечные точки

• Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24 [Срок оценки: Week 24]

Вторичные конечные точки (12)

• Change of Glasgow Ultrasound Enthesitis Scoring System(GUESS) from baseline to week 4, 12, 36, 52 [Срок оценки: Week 4, 12, 36, 52]
• Complete resolution of enthesitis from baseline to week 24 [Срок оценки: Week 24]
• Complete resolution of enthesitis from baseline to week 52 [Срок оценки: Week 52]
• New bone erosion, bursitis, osteophytes at week 24 [Срок оценки: Week 24]
• New bone erosion, bursitis, osteophytes at week 52 [Срок оценки: Week 52]
• Change of patient pain assessment based on Visual Analog Scale (VAS) at week 4, 12, 24, 36, 52 [Срок оценки: Week 4, 12, 24, 36, 52]
• Change of PASI from baseline to week 24, 52 [Срок оценки: Week 24, 52]
• Change of BSA% from baseline to week 24, 52 [Срок оценки: Week 24, 52]
• Change of mNAPSI from baseline to week 24, 52 [Срок оценки: Week 24, 52]
• Change of PSSI from baseline to week 24, 52 [Срок оценки: Week 24, 52]
• Change of HAQ-DI from baseline to week 24, 52 [Срок оценки: Week 24, 52]
• Change of SJC66 and TJC68 from baseline to week 24, 52 [Срок оценки: Week 24, 52]

Критерии участия

Критерии включения

• 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
• Able to sign the informed consent

Критерии исключения

• 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
• Pregnant or lactating women or women with plan for conception 5 months before or after treatment
• Participated in other clinical trials
• 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.
• Any liver function abnormality: aspartate aminotransferase (AST) > 2xULN, alanine aminotransferase (ALT) > 2xULN, total bilirubin (TBIL) > 2xULN
• Abnormal renal function: serum creatinine > 2.0 mg/dl
• 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.
• Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
• History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years
• Unable or unwilling to undergo repeated venipuncture
• History of alcohol or drug abuse or evidence of 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, 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing Universit — Нанкин
• Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing Universit — Нанкин

Публикации

• Schett G, Rahman P, Ritchlin C, McInnes IB, Elewaut D, Scher JU. Psoriatic arthritis from a mechanistic perspective. Nat Rev Rheumatol. 2022 Jun;18(6):311-325. doi: 10.1038/s41584-022-00776-6. Epub 2022 May 5. PMID 35513599
• Chen R, Zhong X, Huang D, Chen Z, Yu Y, Lu J, Wang Q, Kong L, Yi X, Zhao Y, Ding Y, Guo L, Shi Y. Advantages of ultrasound imaging for the early diagnosis of psoriatic arthritis in patients with moderate to severe psoriasis. Heliyon. 2024 Jul 4;10(13):e34136. doi: 10.1016/j.heliyon.2024.e34136. eCollection 2024 Jul 15. PMID 39055795
• Weiner SM, Jurenz S, Uhl M, Lange-Nolde A, Warnatz K, Peter HH, Walker UA. Ultrasonography in the assessment of peripheral joint involvement in psoriatic arthritis : a comparison with radiography, MRI and scintigraphy. Clin Rheumatol. 2008 Aug;27(8):983-9. doi: 10.1007/s10067-008-0835-y. Epub 2008 Feb 8. PMID 18259687
• Balint PV, Kane D, Wilson H, McInnes IB, Sturrock RD. Ultrasonography of entheseal insertions in the lower limb in spondyloarthropathy. Ann Rheum Dis. 2002 Oct;61(10):905-10. doi: 10.1136/ard.61.10.905. PMID 12228161

Идентификаторы

NCT: NCT06987292 · 2025-0301-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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