Studies an IL-17 inhibitor for hidden tendon inflammation in psoriasis

Trial details

Who runs it

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Trial code

NCT06987292

Record updated

23 May 2025

Original description

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)Read full original descriptionShow less

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

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)

Inclusion: 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.

Exclusion: 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; Pregnant or lactating women or women with plan for conception 5 months before or after treatment; History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline; 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); 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; History of hypersensitivity to any component of the study drug; 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; Diagnosis of PsA2 according to CASPAR; Obesity impeded ultrasound examination; Participated in other clinical trials; Unable or unwilling to undergo repeated venipuncture.

ClinicalTrials.gov NCT06987292