← Back to Search

Monoclonal Antibodies

Guselkumab for Psoriasis (TIG Trial)

Phase 4
Recruiting
Led By Wilson Liao, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For subjects with chronic plaque psoriasis (control): At least 18 years of age
For subjects with chronic plaque psoriasis (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
Must not have
For subjects with guttate psoriasis: Have a history of active, chronic or recurrent infectious disease including HIV, hepatitis B, or hepatitis C
For subjects with chronic plaque psoriasis: Known allergies, hypersensitivity, or intolerance to guselkumab (TremfyaTM) excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 44
Awards & highlights

Summary

This trial is testing a new psoriasis drug, guselkumab, to see if it is effective and safe.

Who is the study for?
Adults aged 18-70 with recent onset guttate psoriasis or long-standing plaque psoriasis, covering at least 5% of their body. Participants must be able to consent and follow the study plan. Women who can have children should use effective birth control. Excluded are those with certain infections like TB, HIV, hepatitis B/C, other skin diseases, severe illnesses, history of cancer (with some exceptions), or past psoriasis treatments including biologics.
What is being tested?
The trial is testing guselkumab's effects on two types of psoriasis: new-onset guttate and chronic plaque. It's an open-label study where all participants know they're receiving guselkumab and are monitored for how their immune system responds to the treatment.
What are the potential side effects?
Guselkumab may cause side effects such as allergic reactions to its components, injection site reactions (like pain or swelling), headaches, joint pain, stomach issues and potentially increase the risk of infections due to immune system alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with chronic plaque psoriasis.
Select...
I have chronic plaque psoriasis without any active skin infections or other chronic diseases.
Select...
My guttate psoriasis affects 5% or more of my body.
Select...
I have had plaque psoriasis for more than 5 years.
Select...
I have been diagnosed with plaque psoriasis.
Select...
My psoriasis severity score is 4 or higher.
Select...
I have been diagnosed with guttate psoriasis.
Select...
My psoriasis affects 5% or more of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have guttate psoriasis and no history of HIV, hepatitis B, or C.
Select...
I am allergic to ingredients in Tremfya.
Select...
I am not pregnant, nursing, or planning to become pregnant or father a child during the study and for 12 weeks after.
Select...
I have guttate psoriasis and a history or symptoms of lymph disease.
Select...
I am under 18 or over 70 years old with chronic plaque psoriasis.
Select...
I have had guttate psoriasis before my current chronic plaque psoriasis.
Select...
I am under 18 or over 70 years old with guttate psoriasis.
Select...
I have chronic plaque psoriasis and a history of infections like HIV or hepatitis.
Select...
I am allergic or sensitive to ingredients in Tremfya.
Select...
I have had psoriasis for more than 6 months.
Select...
My guttate psoriasis is severe, getting worse, or not under control.
Select...
I am not pregnant, nursing, or planning to become pregnant or father a child during the study and for 12 weeks after.
Select...
I have psoriasis and a history or signs of lymphatic system disease.
Select...
My psoriasis is severe, getting worse, or not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 44
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 44 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lesional CD4+ T effector cells
Lesional CD8+ T effector cells

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

Trial Design

2Treatment groups
Experimental Treatment
Group I: New-onset guttate psoriasisExperimental Treatment1 Intervention
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.
Group II: Chronic plaque psoriasisExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,861 Total Patients Enrolled
15 Trials studying Psoriasis
315 Patients Enrolled for Psoriasis
Janssen Biotech, Inc.Industry Sponsor
29 Previous Clinical Trials
18,784 Total Patients Enrolled
6 Trials studying Psoriasis
3,246 Patients Enrolled for Psoriasis
Wilson Liao, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Psoriasis
31 Patients Enrolled for Psoriasis

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04645355 — Phase 4
Psoriasis Research Study Groups: Chronic plaque psoriasis, New-onset guttate psoriasis
Psoriasis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04645355 — Phase 4
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04645355 — Phase 4
~2 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top