Guselkumab Immunogenetics (TIG)

March 6, 2024 updated by: University of California, San Francisco

Immunogenetic Profiling of Guselkumab for the Treatment of Plaque and Guttate Psoriasis

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Guselkumab (Tremfya®), an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis. Given the potential role of IL-23 in the pathogenesis of guttate psoriasis, guselkumab may be an effective option to treat the initial manifestation of guttate psoriasis. 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. The primary objective of this study is to assess how treatment with guselkumab changes the immune milieu of the skin in patients with plaque or guttate psoriasis. The secondary objectives of this study are to assess how treatment with guselkumab affects the quality of life and extent of skin disease in patients with plaque or guttate psoriasis.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • San Francisco, California, United States, 94118
        • Recruiting
        • UCSF Psoriasis and Skin Treatment Center
        • Contact:
        • Principal Investigator:
          • Wilson Liao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.
  • Body surface area (BSA) involvement greater than or equal to 5%.
  • 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.

Exclusion Criteria:

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.)

For subjects with chronic plaque 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 plaque psoriasis.
  • Prior history of guttate psoriasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44
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.
All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesional CD4+ T effector cells
Time Frame: baseline and week 44
Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17
baseline and week 44
Lesional CD8+ T effector cells
Time Frame: baseline and week 44
Mean change from baseline in percent of lesional CD8+ T effector cells producing IL-17
baseline and week 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Wilson Liao, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-32273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identifying clinical and research data may be shared with Janssen Biotech, UCSF and FDA, as well as other qualified scientists upon publication and upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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