Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT06987292
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06987292
Study Brief:
Protocol Section:
NCT06987292