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)
Recruiting now
Conditions studied: Psoriasis (PsO), Enthesitis, Psoriasis Arthritis, Secukinumab
In brief
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)
Key facts
- Study ID
- NCT06987292
- Run by
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- People needed
- 50
- Starts
- 2025-05-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)
- Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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