Immune Spatial Features of Guselkumab Cutaneous Response

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05858632

Enrollment

Registered

2023-05-15

Start date

2023-07-01

Completion date

2028-06-30

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis of Scalp

Brief 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.

Interventions

DRUGGuselkumab

Guselkumab treatment for \~ 9 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Change in psoriasis scalp severity index score (PSSI)	baseline and 9 months	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.

Countries

United States

Contacts

CONTACTJeffrey Cheng, MD, PhD

rashes@ucsf.edu415 575 0524

CONTACTRaymond Cho, MD,PhD

PRINCIPAL_INVESTIGATORRaymond Cho, MD, PhD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026