NCT05858632

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
2mo left

Started Jul 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jun 2026

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

May 4, 2023

Last Update Submit

August 25, 2023

Conditions

Psoriasis of Scalp

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Guselkumab treatment

EXPERIMENTAL

Guselkumab treatment for \~ 9 months

Drug: Guselkumab

Interventions

GuselkumabDRUG

Guselkumab treatment for \~ 9 months

Guselkumab treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Interventions

guselkumab

Study Officials

  • Raymond Cho, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Cheng, MD, PhD

CONTACT

415 575 0524rashes@ucsf.edu

Raymond Cho, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)