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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05858632
Other study ID # 21-35862
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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 -

Study Design


Related Conditions & MeSH terms


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
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Completed NCT00216879 - Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis Phase 3
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