Status:
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)
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Psoriasis (PsO)
Enthesitis
Eligibility:
All Genders
18+ years
Brief Summary
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 ps...
Eligibility Criteria
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
- 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)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06987292
Start Date
May 1 2025
End Date
December 31 2027
Last Update
May 23 2025
Active Locations (2)
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1
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
2
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008