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NCT Number: NCT05858632

Immune Spatial Features of Guselkumab Cutaneous Response

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

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Key information

Conditions

Psoriasis of Scalp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Francisco

San Francisco, California, 94115, United States

Location status: Recruiting

Location contact

Jeffrey Cheng, MD, PhD

CONTACT

[email protected]

415-575-0524

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Guselkumab

Drug

Guselkumab treatment for ~ 9 months

Primary outcomes

  1. Change in psoriasis scalp severity index score (PSSI)

    Time frame: baseline and 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Cheng, MD, PhD

CONTACT

[email protected]

415 575 0524

Raymond Cho, MD,PhD

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 15, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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