NCT05858632PHASE4RecruitingAccepts Healthy Volunteers
Immune Spatial Features of Guselkumab Cutaneous Response
University of California, San Francisco
Start Date
7/1/2023
Completion Date
6/30/2028
Summary
This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.
Detailed Description
This is a one-arm, open-label study to examine the effect of Guselkumab . Guselkumab is a FDA-approved medication for the treatment of psoriasis. This study will examine how Guselkumab affects immune cells within scalp psoriasis lesions. Ten subjects with moderate to severe scalp psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with Guselkumab treatment response.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria: possess a PSSI (psoriasis scalp severity index) of ≥12
Exclusion Criteria:
1. taking systemic immunosuppressives in the last 4 weeks
2. pregnancy
3. severe immunodeficiency (either from genetic or infectious causes).
4. tuberculosis or other active serious infection
5. active systemic malignancy.
6. breast-feeding
7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
8. Males who are trying to conceive
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Interventions
DRUG
Guselkumab
Conditions
Psoriasis of Scalp
Locations
University of California San Francisco
San Francisco, California 94115
United States