Immune Spatial Features of Guselkumab Cutaneous Response

Psoriasis of Scalp Clinical Trial

Official title:

Immune Spatial Features of Guselkumab Cutaneous Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858632
• Other study ID #: 21-35862
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Jeffrey Cheng, MD, PhD
• Phone: 415 575 0524
• Email: rashes[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis of Scalp

Intervention

Drug:
• Guselkumab
Guselkumab treatment for ~ 9 months

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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