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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT07290569
Eligibility Criteria:
Inclusion Criteria:
1. Participants ≥ 18 years of age
2. Have a diagnosis of plaque psoriasis for \> 6 months
3. Have moderate-to-severe chronic plaque psoriasis defined as:
1. BSA ≥ 10%, and
2. PASI ≥ 12, and
3. IGA score of ≥ 3 on a 5-point scale
4. Candidate for systemic therapy or phototherapy
5. Women of childbearing potential must have a negative pregnancy test.
Exclusion Criteria:
1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
4. A known hypersensitivity to any components of the ORKA-001 drug product
5. Women who are breastfeeding or plan to breastfeed during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07290569
Study Brief:
Protocol Section:
NCT07290569