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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT05270733
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with plaque-type psoriasis defined by either:
* A board-certified dermatologist, OR
* Dermatology Nurse Practitioner, OR
* Skin punch biopsy
* Insurance that includes an anti-p40 biologic (ustekinumab/.Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)
* Must be naive to ustekinumab, guselkumab, and risankizumab.
* Involvement of body surface area (BSA) of at least 10% at screening and baseline visit.
* Able to give informed consent under IRB approval procedures
Exclusion Criteria:
* Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study.
* Inability to provide informed consent
* Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial
* Use of tanning booths for at least 4 weeks prior to baseline visit
* Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit and for duration of trial
* Current or recent use of systemic or biologic therapy for at least 8 weeks prior to baseline visit
* Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05270733
Study Brief:
Protocol Section:
NCT05270733