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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests guselkumab, a treatment for psoriasis, to evaluate its effectiveness for individuals with plaque or guttate psoriasis. Researchers aim to understand how well this treatment reduces symptoms and what genetic factors might influence its effectiveness. Participants will receive regular doses of guselkumab and will be monitored for changes in their condition. Individuals with chronic plaque psoriasis for over 5 years or new-onset guttate psoriasis within the last year may be suitable for the trial. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have previously been treated for psoriasis with certain therapies like phototherapy, systemic agents, or biologic agents, you may not be eligible to participate.

What is the safety track record for this treatment?

Research shows that guselkumab, the treatment under study in this trial, is generally safe for people with psoriasis. Studies have found that adults with moderate-to-severe plaque psoriasis usually tolerate guselkumab well. Used for over five years, it has demonstrated a good safety record. The most common side effects are mild, such as upper respiratory infections, and occur in less than 1% of people.

Evidence also supports guselkumab's safety for children with moderate to severe plaque psoriasis, reinforcing its safety for many patients. Overall, research suggests that guselkumab is a safe option for treating psoriasis. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Guselkumab is unique because it specifically targets interleukin-23 (IL-23), a protein that plays a key role in the inflammation and overproduction of skin cells seen in psoriasis. Unlike traditional treatments like methotrexate or cyclosporine, which can have broad immune-suppressing effects, guselkumab offers a more targeted approach, potentially reducing side effects. Researchers are excited about guselkumab because its precise action may lead to longer-lasting results and fewer relapses while improving the quality of life for those with chronic plaque and new-onset guttate psoriasis.

What is the effectiveness track record for guselkumab in treating psoriasis?

Research has shown that guselkumab effectively treats both plaque psoriasis and guttate psoriasis. In this trial, participants with chronic plaque psoriasis will receive guselkumab, and 64% of patients in previous studies experienced significant skin improvement, known as PASI 90, after 16 weeks. Real-world studies indicate that many patients report better disease control and quality of life with regular treatment. Participants with new-onset guttate psoriasis will also receive guselkumab, and early studies suggest it is promising, with improvements seen regardless of how long patients have had the condition. Overall, guselkumab has a history of reducing symptoms and clearing skin in people with psoriasis. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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

I am allergic to ingredients in Tremfya.

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?

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+

Citations

1. tremfya.com tremfya.com/plaque-psoriasis/results/

study results In one clinical study, 5 out of 10 patients saw completely clear skin at 16 weeks. IMPROVED SYMPTOMS AT 16 WEEKS. In clinical studies, at 16 weeks, patients had ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884726/

Effectiveness of Guselkumab Therapy among Patients with ... In this real-world study, patients with a baseline IGA score ≥ 2 experienced improvements in disease activity and PROMs after 9–12 months of persistent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354356/

Guselkumab Retention, Effectiveness, and Safety in Psoriasis Drug survival overall remained stable and similar, with 79.5% (95% confidence interval (CI) 76.9–81.9) of patients without PsA and 78.5% (95% CI 72.9–83.1) of ...

4. tremfyahcp.com tremfyahcp.com/plaque-psoriasis/skin-clearance-data/

Skin Clearance Data: Moderate to Severe Plaque PsO Clearer skin is possible · 64% (102/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 16 · 71% (113/160) of patients receiving TREMFYA® ...

5. jnj.com jnj.com/media-center/press-releases/tremfya-guselkumab-real-world-data-analyses-show-greater-treatment-persistence-than-il-17s-in-both-bio-naive-and-bio-experienced-patients-living-with-moderate-to-severe-plaque-psoriasis

TREMFYA® (guselkumab) Real-World Data Analyses ... Additional post-hoc analysis of TREMFYA showed improvements in scalp psoriasis and quality-of-life measures at week 48.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37022762/

Safety of guselkumab treatment for up to 5 years in patients ... Guselkumab has demonstrated favourable safety and efficacy across individual clinical studies in adults with moderate-to-severe plaque psoriasis.

7. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/tremfya

Tremfya | European Medicines Agency (EMA) Long-term safety data have shown that it has few side effects. For patients with moderately to severely active ulcerative colitis and Crohn's disease, the ...

8. tremfyahcp.com tremfyahcp.com/psoriatic-arthritis/safety/

Safety Profile In Active PsA | TREMFYA® (guselkumab) HCP Most common adverse reactions associated with TREMFYA® include: plaque psoriasis and psoriatic arthritis adverse reactions (≥1%): upper respiratory infections, ...

9. tremfyahcp.com tremfyahcp.com/plaque-psoriasis/safety/

Safety Profile for Moderate to Severe Plaque PsO See the TREMFYA® (guselkumab) safety profile in adult patients with moderate to severe plaque psoriasis (PsO). See full Prescribing & Safety Info.

10. jnj.com jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-for-the-treatment-of-pediatric-plaque-psoriasis-and-active-psoriatic-arthritis-marking-a-first-and-only-approval-for-an-il-23-inhibitor

U.S. FDA approves TREMFYA® (guselkumab) for the ... TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or ...