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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

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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

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I am 18 or older with chronic plaque psoriasis.

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I have chronic plaque psoriasis without any active skin infections or other chronic diseases.

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My guttate psoriasis affects 5% or more of my body.

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I have had plaque psoriasis for more than 5 years.

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I have been diagnosed with plaque psoriasis.

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My psoriasis severity score is 4 or higher.

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I have been diagnosed with guttate psoriasis.

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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:

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I have guttate psoriasis and no history of HIV, hepatitis B, or C.

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I am allergic to ingredients in Tremfya.

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I am not pregnant, nursing, or planning to become pregnant or father a child during the study and for 12 weeks after.

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I have guttate psoriasis and a history or symptoms of lymph disease.

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I am under 18 or over 70 years old with chronic plaque psoriasis.

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I have had guttate psoriasis before my current chronic plaque psoriasis.

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I am under 18 or over 70 years old with guttate psoriasis.

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I have chronic plaque psoriasis and a history of infections like HIV or hepatitis.

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I am allergic or sensitive to ingredients in Tremfya.

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I have had psoriasis for more than 6 months.

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My guttate psoriasis is severe, getting worse, or not under control.

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I am not pregnant, nursing, or planning to become pregnant or father a child during the study and for 12 weeks after.

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I have psoriasis and a history or signs of lymphatic system disease.

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My psoriasis is severe, getting worse, or not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 44

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

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

0 / 22Eligibility criteria met