Immune Spatial Features of Guselkumab Cutaneous Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guselkumab.
- Who it may be relevant to
- Registry conditions: Psoriasis of Scalp. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Guselkumab
Guselkumab treatment for \~ 9 months
Primary outcome measures
- Change in psoriasis scalp severity index score (PSSI) [Time frame: baseline and 9 months]
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of California San Francisco — San Francisco
Identifiers
NCT: NCT05858632 · 21-35862