Examining how Guselkumab affects immune cells in scalp psoriasis
Immune Spatial Features of Guselkumab Cutaneous Response
This study is testing how the medication Guselkumab affects immune cells in people with moderate to severe scalp psoriasis to see how it helps their condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | Guselkumab |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05858632 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Guselkumab, an FDA-approved medication for psoriasis, on immune cells in scalp psoriasis lesions. It is a one-arm, open-label study involving ten subjects with moderate to severe scalp psoriasis. Participants will undergo biopsy procedures to collect samples for molecular profiling, which will help correlate immune cell profiles with treatment responses to Guselkumab. The goal is to better understand the immune spatial features associated with the drug's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate to severe scalp psoriasis, indicated by a psoriasis scalp severity index (PSSI) of 12 or higher.
Not a fit: Patients currently taking systemic immunosuppressives, pregnant, or with severe immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for patients with scalp psoriasis by providing insights into immune responses to Guselkumab.
How similar studies have performed: Other studies have shown success with IL-23 blockade therapies in psoriasis, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \-
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Raymond Cho, MD, PhD — University of California, San Francisco
- Study coordinator: Jeffrey Cheng, MD, PhD
- Email: rashes@ucsf.edu
- Phone: 415 575 0524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.