Guselkumab for Psoriasis

(TIG Trial)

Overseen By Wilson Liao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Biologics, Systemics, Phototherapy, others

Disqualifiers: Infectious disease, Tuberculosis, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 44 weeks

25 Participants Needed

Trial Summary

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.

Research Team

Wilson Liao, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: New-onset guttate psoriasis Experimental Treatment 1 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 psoriasis Experimental Treatment 1 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.

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

Approved in United States as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

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+