Back to resultsImmune Spatial Features of Guselkumab Cutaneous Response
Primary Purpose
Psoriasis of Scalp
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guselkumab
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis of Scalp
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 -
Sites / Locations
- University of California San FranciscoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Guselkumab treatment
Arm Description
Guselkumab treatment for ~ 9 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05858632
First Posted
May 4, 2023
Last Updated
August 25, 2023
Sponsor
University of California, San Francisco
Collaborators
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05858632
Brief Title
Immune Spatial Features of Guselkumab Cutaneous Response
Official Title
Immune Spatial Features of Guselkumab Cutaneous Response
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Janssen Scientific Affairs, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis of Scalp
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guselkumab treatment
Arm Type
Experimental
Arm Description
Guselkumab treatment for ~ 9 months
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Intervention Description
Guselkumab treatment for ~ 9 months
Primary Outcome Measure Information:
Title
Change in psoriasis scalp severity index score (PSSI)
Description
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.
Time Frame
baseline and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Cheng, MD, PhD
Phone
415 575 0524
Email
rashes@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Cho, MD,PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Cho, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Cheng, MD, PhD
Phone
415-575-0524
Email
rashes@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immune Spatial Features of Guselkumab Cutaneous Response
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