Immune Spatial Features of Guselkumab Cutaneous Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Psoriasis of Scalp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Guselkumab treatment

Guselkumab treatment for \~ 9 months

Group Type EXPERIMENTAL

Guselkumab

Intervention Type DRUG

Guselkumab treatment for \~ 9 months

Interventions

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Guselkumab

Guselkumab treatment for \~ 9 months

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes