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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT04239859
Eligibility Criteria:
Inclusion Criteria:
* Adults (\>21-year-old).
* Diagnosed by dermatologist as plague-type PsO.
* Having moderate to severe plague-type PsO as defined by the following:
* Psoriasis Area and Severity Index (PASI) ≥12/72,
* And, investigator Global Assessment Score (IGA) ≥3,
* And, PsO involving body surface area involvement (BSA) ≥10%
* And Candidate for phototherapy and/or systemic therapy
* Topical corticosteroid up to moderate potencies are allowed
* Able to provide informed consent.
Exclusion Criteria:
* Forms of PsO other than plaque-type.
* Evidence of skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluation of the effect of the investigational product on PsO.
* Evidence of active tuberculosis or other active infections (like Hepatitis C/B), malignancy; active or known use of other immunosuppressive drugs (eg. AIDS, rheumatoid arthritis, organ rejection etc) at the screening visit.
* Previous exposure to any systemic immunosuppressants (eg. methotrexate) or phototherapy
* History or current signs of a severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
* Having current or history of malignancy, except non-melanoma skin cancer, within the previous 5 years that have been adequately treated.
* History of inflammatory bowel disease.
* Pregnancy or lactating mothers.
* As treatment regimen is different, participants with evidence of PsA will be excl
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
90 Years
Study:
NCT04239859
Study Brief:
Protocol Section:
NCT04239859