NCT06987292 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)
| NCT ID | NCT06987292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Psoriasis (PsO) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-05-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06987292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis (PsO). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06987292 currently recruiting?
Yes, NCT06987292 is actively recruiting participants. Contact the research team at hwjnanjing@126.com for enrollment information.
Where is the NCT06987292 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China.
Who is sponsoring the NCT06987292 clinical trial?
NCT06987292 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 50 participants.
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