Immune Spatial Features of Guselkumab Cutaneous Response

Phase 4RecruitingNCT05858632

University of California, San Francisco10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Psoriasis of Scalp

Interventions

GuselkumabDRUG

Guselkumab treatment for \~ 9 months

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

University of California San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change in psoriasis scalp severity index score (PSSI)

PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. PSSI scores will be taken pre- and mid-treatment. Scores range from 0 to 72, with higher scores indicating more severity.

Time frame: baseline and 9 months

Central Contacts

Jeffrey Cheng, MD, PhD

CONTACT

415 575 0524 rashes@ucsf.edu

Raymond Cho, MD,PhD

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.