Immune Spatial Features of Guselkumab Cutaneous Response

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05858632
• Collaborator: Janssen Scientific Affairs, LLC (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis of Scalp	Drug: Guselkumab	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Immune Spatial Features of Guselkumab Cutaneous Response
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94115

Sponsors and Collaborators

• University of California, San Francisco
• Janssen Scientific Affairs, LLC

Investigators

• Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05858632
• Other Study ID Numbers: 21-35862
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of May 15, 2023