Immune Spatial Features of Guselkumab Cutaneous Response | NCT05858632

Studies
Immune Spatial Features of Guselkumab Cutaneous Response

NCT05858632

Sponsor

University of California, San Francisco

Status

Recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

10Estimated

Phase

Phase 4

Conditions

Psoriasis of Scalp

Interventions

Guselkumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

May 4, 2023

First Submission Date that Met QC Criteria

May 4, 2023

First Posted Date

May 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 4, 2026Actual

Name	Class
Janssen Scientific Affairs, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Guselkumab treatment	Experimental	Guselkumab treatment for ~ 9 months	Drug: Guselkumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab	Drug	Guselkumab treatment for ~ 9 months	Guselkumab treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: possess a PSSI (psoriasis scalp severity index) of ≥12

Exclusion Criteria:

taking systemic immunosuppressives in the last 4 weeks
pregnancy
severe immunodeficiency (either from genetic or infectious causes).
tuberculosis or other active serious infection
active systemic malignancy.
breast-feeding
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.
Males who are trying to conceive

-

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeffrey Cheng, MD, PhD	Contact	415 575 0524		rashes@ucsf.edu
Raymond Cho, MD,PhD	Contact

Overall Officials

Name	Affiliation	Role
Raymond Cho, MD, PhD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco	Recruiting	San Francisco	California	94115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided