Immune Spatial Features of Guselkumab Cutaneous Response

Phase 4

Recruiting

• Conditions: Psoriasis of Scalp
• Interventions: Drug: Guselkumab

• Registration Number: NCT05858632
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-15
• Study Start: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guselkumab treatment	Guselkumab	Guselkumab treatment for \~ 9 months

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States