Immune Spatial Features of Guselkumab Cutaneous Response

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Psoriasis of Scalp

Treatments: Drug: Guselkumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05858632

21-35862

Details and patient eligibility

About

This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Guselkumab treatment

Experimental group

Description:

Guselkumab treatment for \~ 9 months

Treatment:

Drug: Guselkumab