25 Participants Needed

Guselkumab for Psoriasis

(TIG Trial)

NB
MH
WL
Overseen ByWilson Liao, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

WL

Wilson Liao, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am not likely to conceive due to being male, post-menopausal, or using effective birth control.
I am 18 or older with chronic plaque psoriasis.
I have chronic plaque psoriasis without any active skin infections or other chronic diseases.
See 14 more

Exclusion Criteria

I have guttate psoriasis and no history of HIV, hepatitis B, or C.
For subjects with chronic plaque psoriasis: Are participating in another study using an investigational agent or procedure during participation in this study
For subjects with chronic plaque psoriasis: Subject is unable to provide written informed consent or comply with the protocol
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks until week 44

44 weeks
Visits at weeks 0, 4, and every 8 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants who achieve PASI 50-75 continue treatment; those achieving PASI 75 or greater have therapy withdrawn and are re-treated upon relapse

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Guselkumab
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: New-onset guttate psoriasisExperimental Treatment1 Intervention
Group II: Chronic plaque psoriasisExperimental Treatment1 Intervention

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tremfya for:
🇪🇺
Approved in European Union as Tremfya for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Janssen Biotech, Inc.

Industry Sponsor

Trials
30
Recruited
18,800+
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