Immune Spatial Features of Guselkumab Cutaneous Response

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

Study Overview

• Status: Recruiting
• Conditions: Psoriasis of Scalp
• Intervention / Treatment: Drug: Guselkumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeffrey Cheng, MD, PhD; Phone Number: 415 575 0524; Email: rashes@ucsf.edu
• Study Contact Backup: Name: Raymond Cho, MD,PhD

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • University of California San Francisco
      • Contact: Jeffrey Cheng, MD, PhD; Phone Number: 415-575-0524; Email: rashes@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guselkumab treatment; Guselkumab treatment for ~ 9 months	Drug: Guselkumab; Guselkumab treatment for ~ 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 9 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Janssen Scientific Affairs, LLC
• Investigators: Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 21-35862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No