Guselkumab Immunogenetics

NCT04645355 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20-32273
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Guttate; Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Lesional CD4+ T effector cells

  Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17

  baseline and week 44

• Lesional CD8+ T effector cells

  Mean change from baseline in percent of lesional CD8+ T effector cells producing IL-17

  baseline and week 44

Study Arms (2)

New-onset guttate psoriasis

EXPERIMENTAL

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 Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.

Drug: Guselkumab

Chronic plaque psoriasis

EXPERIMENTAL

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 Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.

Drug: Guselkumab

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

Chronic plaque psoriasis; New-onset guttate psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For subjects with guttate psoriasis:
• Ability to provide written informed consent and comply with the protocol.
• At least 18 years of age.
• Diagnosis of guttate psoriasis.
• Onset of guttate psoriasis within 12 months.
• Body surface area (BSA) involvement greater than or equal to 5%.
• PASI greater than or equal to 4.
• Subject is considered a candidate for phototherapy or systemic therapy.
• Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods). Women of childbearing potential will be allowed to enroll provided they practice adequate forms of birth control.
• Physical exam with no evidence of active skin infection and/or other findings that indicate chronic disease or concomitant inflammatory/immune-mediated skin disease other than psoriasis.
• For subjects with chronic plaque psoriasis (control):
• Ability to provide written informed consent and comply with the protocol.
• At least 18 years of age.
• Diagnosis of plaque psoriasis.
• Duration of plaque psoriasis \>5 years.

You may not qualify if:

• For subjects with guttate psoriasis:
• Subject is unable to provide written informed consent or comply with the protocol.
• Subject is younger than 18 years of age or older than 70 years.
• Have a history of active, chronic or recurrent infectious disease including HIV, hepatitis B, or hepatitis C.
• Have active tuberculosis or latent tuberculosis without at least 4 weeks of treatment with isoniazid.
• Have current signs or symptoms of severe, progressive, or uncontrolled medical disease.
• Known allergies, hypersensitivity, or intolerance to guselkumab (TremfyaTM) excipients.
• Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
• Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening)
• Are pregnant, nursing, or planning a pregnancy while enrolled in the study or for 12 weeks after the study agent injection for women or are planning to father a child while enrolled in the study or for 12 weeks after the last study agent injection.
• Are participating in another study using an investigational agent or procedure during participation in this study.
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
• Subjects possess other diagnoses that, in the investigator's opinion interfere with the evaluation of the subject's guttate psoriasis.
• Pre-existing psoriasis of any type for longer than 6 months. (i.e. plaque, guttate, palmoplantar, pustular, erythrodermic)
• Previous treatment for psoriasis with phototherapy (narrowband ultraviolet (UV) B, broadband UVB, or UVA), systemic agents (methotrexate, acitretin, cyclosporine, apremilast), or biologic agents (etanercept, adalimumab, ustekinumab, secukinumab, etc.)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Guttate Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wilson Liao, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, open-label study. Twenty-five subjects are planned (15 with new-onset guttate psoriasis and 10 with chronic plaque psoriasis). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. 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 Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: March 1, 2021
• Primary Completion: April 4, 2025
• Study Completion: April 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)