Guselkumab for Psoriasis

(VISIBLE Trial)

No longer recruiting at 105 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Ustekinumab, Ixekizumab, Secukinumab, Brodalumab

Disqualifiers: Nonplaque psoriasis, Severe infections, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of guselkumab for individuals with moderate-to-severe psoriasis, focusing on skin of color. Participants will initially receive either guselkumab or a placebo (inactive substance), but those on the placebo will later switch to guselkumab. The trial seeks individuals who have had plaque psoriasis for at least six months, self-identify as non-white, and are suitable candidates for phototherapy or systemic treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken certain psoriasis medications like ustekinumab, ixekizumab, secukinumab, or brodalumab, you must have stopped them at least 12 weeks before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that guselkumab, a treatment for moderate-to-severe psoriasis, is generally safe. In studies with adults who have moderate-to-severe plaque psoriasis, participants tolerated the treatment well over several years. Common side effects include mild to moderate issues like headaches or colds, while serious side effects are rare. This treatment is already approved for plaque psoriasis, indicating it has passed many safety checks for that condition. Those considering joining a trial for scalp psoriasis might find reassurance in guselkumab's safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Guselkumab is unique because it targets a specific protein called interleukin-23 (IL-23), which plays a crucial role in the inflammation process associated with psoriasis. Unlike standard treatments like methotrexate or cyclosporine, which can have broad effects on the immune system, guselkumab's precision in targeting IL-23 is designed to reduce inflammation more effectively and with fewer side effects. Researchers are excited about guselkumab because it offers a targeted approach that could lead to better outcomes for patients with moderate-to-severe plaque and scalp psoriasis, potentially offering clearer skin with improved safety.

What evidence suggests that guselkumab might be an effective treatment for psoriasis?

This trial will evaluate guselkumab for both moderate-to-severe plaque psoriasis and moderate-to-severe scalp psoriasis. Studies have shown that guselkumab effectively treats moderate-to-severe plaque psoriasis, with 64% of patients experiencing a 90% improvement in symptoms by week 16. For moderate-to-severe scalp psoriasis, guselkumab also showed promise, with nearly 7 in 10 patients experiencing significant relief from scalp itch compared to a much lower percentage in the placebo group. These findings suggest that guselkumab can help achieve clearer skin and reduce symptoms for both types of psoriasis. Participants in this trial will receive either guselkumab or a placebo, with placebo participants later crossing over to receive guselkumab. ^{6 7 8 9 10}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for non-white individuals with moderate-to-severe plaque or scalp psoriasis. Participants must have a body surface area involvement of at least 10% or a scalp surface area of at least 30%, among other severity criteria. They should not have received certain psoriasis treatments recently and cannot get live vaccines during the study.

Inclusion Criteria

I agree not to get a BCG vaccine during and for 12 weeks after the study.

I agree not to get any live vaccines during or up to 12 weeks after the study.

You are not white or of Caucasian descent.

Exclusion Criteria

I have severe ongoing health issues affecting my organs or mental health.

My psoriasis is not the common plaque type.

You are allergic or have bad reactions to guselkumab or its ingredients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guselkumab or placebo subcutaneously, with placebo participants crossing over to guselkumab

16 weeks

Regular visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 100 weeks

Periodic visits for safety assessments

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab
• Placebo

Trial Overview The study tests the effectiveness of Guselkumab, an injectable medication, compared to a placebo in improving symptoms of psoriasis in skin of color participants. The goal is to see if there's significant improvement in those receiving Guselkumab.

How Is the Trial Designed?

Group I: Cohort B: Moderate-to-severe Scalp Psoriasis Experimental Treatment 2 Interventions

Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Group II: Cohort A: Moderate-to-severe Plaque Psoriasis Experimental Treatment 2 Interventions

Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

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?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Guselkumab is an approved treatment for moderate-to-severe plaque psoriasis, specifically designed to inhibit interleukin 23 (IL-23), which plays a key role in the inflammatory process of the disease.

By blocking IL-23 from binding to its receptor, guselkumab disrupts the IL-17 pathway, which is crucial for the activation of type 17 helper T cells, thereby reducing inflammation and symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. Markham, A.[2019]

Guselkumab has a favorable safety profile over 5 years of treatment for moderate-to-severe psoriasis, with low rates of serious adverse events such as serious infections (0.85/100 patient-years) and nonmelanoma skin cancer (0.34/100 patient-years).

Out of 1721 patients treated with guselkumab, 78.4% continued treatment through week 252, indicating good long-term adherence and effectiveness in managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistent safety profile with up to 5 years of continuous treatment with guselkumab: Pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis. Blauvelt, A., Tsai, TF., Langley, RG., et al.[2022]

Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.

Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. Al-Salama, ZT., Scott, LJ.[2019]

Guselkumab is a human monoclonal antibody that selectively blocks IL-23, which is important in the development of psoriasis and psoriatic arthritis, and it was approved for treating active psoriatic arthritis based on data from two phase-3 studies (DISCOVER-1 and -2).

This treatment represents a new therapeutic option for patients with active psoriatic arthritis, demonstrating both efficacy and safety, and it is the first selective IL-23 inhibitor to receive FDA approval for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. Boehncke, WH., Brembilla, NC., Nissen, MJ.[2021]

Guselkumab demonstrated superior efficacy in treating moderate-to-severe plaque psoriasis compared to both placebo and adalimumab, with significant improvements in key measures such as the Psoriasis Area and Severity Index (PASI 75) and the Investigator's Global Assessment (IGA) scores.

The safety profile of guselkumab was comparable to that of placebo and adalimumab, showing no significant increase in adverse events or serious infections, indicating it is a well-tolerated treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials. Yang, J., Wang, Z., Zhang, X.[2022]

A total of 24,312 adverse event reports related to guselkumab were identified from over 22 million reports in the FDA adverse event reporting system, indicating a significant volume of data for analysis.

The study revealed unexpected adverse events associated with guselkumab, including onychomadesis, malignant melanoma in situ, endometrial cancer, and erectile dysfunction, highlighting the need for ongoing safety monitoring and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of guselkumab in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system. Xiang, DC., Chen, W., Fu, ZW., et al.[2023]

In a study of 992 patients over 4 years, continuous treatment with guselkumab showed high efficacy in treating moderate-to-severe psoriasis, with 92.3% of patients maintaining at least a 75% improvement in their condition by week 204.

Guselkumab was well tolerated throughout the study, with no new safety concerns identified, indicating it is a safe long-term treatment option for psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study. Reich, K., Armstrong, AW., Foley, P., et al.[2021]

Citations

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

study results TREMFYA® has been clinically studied and proven effective at helping patients with moderate to severe plaque psoriasis achieve clearer skin and fewer symptoms.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39093650/

Real-life Effectiveness and Safety of Guselkumab in ... At each visit, we used the Psoriasis Area and Severity Index (PASI): effectiveness endpoints were the percentages of patients achieving 75%/90% ...

3. 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® ...

4. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2835459

Guselkumab for Moderate to Severe Psoriasis Across All ... Results provide important clinical data showing that guselkumab is highly effective for the treatment of moderate to severe plaque psoriasis ...

5. jnj.com jnj.com/media-center/press-releases/new-spectrem-study-findings-reveal-tremfya-guselkumab-effectively-clears-overlooked-and-undertreated-plaque-psoriasis

New SPECTREM study findings reveal TREMFYA® ... Treatment with TREMFYA (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis ...

6. 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.

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

Safety Profile in Active PsA | TREMFYA® (guselkumab) HCP TREMFYA proven safety profile through 2 years. Adverse events reported in the placebo-controlled phase through Week 24 combined across DISCOVER 1 and DISCOVER ...

8. 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.

9. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2835458

Guselkumab for Moderate to Severe Scalp Psoriasis ... This randomized clinical trial evaluates efficacy, quality of life, and adverse event outcomes of guselkumab, 100 mg, among participants ...

10. tremfya.com tremfya.com/plaque-psoriasis/

Plaque Psoriasis (PsO) | TREMFYA® (guselkumab) Learn about TREMFYA® (guselkumab) and how it is used to treat plaque psoriasis (PsO). See full Prescribing & Safety Information.