Guselkumab Immunogenetics

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04645355
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Guselkumab — DRUG
    All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44

Study Details

This is a two-arm open-label study to evaluate the clinical and immunogenetic responses of patients with plaque or guttate psoriasis to treatment with guselkumab.

Key Dates

Start date
Mar 1, 2021
Status verified
Mar 2026
Primary completion
Apr 4, 2025
Completion
Apr 15, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: New-onset guttate psoriasis
    Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
  • Experimental: Chronic plaque psoriasis
    Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.

Primary Outcome Measure

Lesional CD4+ T effector cells [ Time Frame: baseline and week 44 ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Psoriasis and Skin Treatment CenterSan FranciscoCalifornia94118-

Find similar trials in San Francisco, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
UCSF Psoriasis and Skin Treatment Center· San Francisco, CA

Related Studies