Guselkumab for Psoriasis

(PAMPA Trial)

Recruiting at 5 trial locations

Overseen By Stephanie Eichman

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must not be taking: Immunosuppressives, Biologics

Disqualifiers: Inflammatory joint pain, Active malignancy, RA, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug guselkumab (Tremfya) can prevent psoriasis from progressing to psoriatic arthritis, which causes joint pain and swelling. Researchers will compare guselkumab to standard treatments and a placebo to assess its effectiveness in reducing specific signs of inflammation in the skin and muscles. Participants who have had psoriasis for over two years, with significant skin involvement and specific ultrasound findings, may be suitable for this trial. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.

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

Yes, you must stop taking current systemic immunosuppressive medications like methotrexate or apremilast, and you cannot have ever used biologic therapy.

What is the safety track record for Guselkumab?

Studies have shown that guselkumab is generally well-tolerated in adults with moderate-to-severe psoriasis. Many patients experience significant skin improvement, with some noticing changes as early as 16 weeks. Research indicates that about 42% of patients taking guselkumab report side effects, compared to 68% of those taking a placebo. This suggests guselkumab might cause fewer side effects than no active treatment. Additionally, the drug has a reliable track record over time, with most patients continuing treatment successfully.

The FDA has approved guselkumab for treating plaque psoriasis and psoriatic arthritis, indicating well-documented safety. However, like any treatment, it may not suit everyone. Always discuss with a doctor if considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for psoriasis, which often include topical therapies, phototherapy, or systemic medications, Guselkumab offers a novel approach by specifically targeting interleukin-23 (IL-23), a key protein involved in the inflammatory process of psoriasis. This targeted mechanism of action may lead to more effective control of symptoms with potentially fewer side effects compared to broader immunosuppressants. Researchers are excited about Guselkumab because its precision in targeting IL-23 could translate into more durable remission and improved quality of life for patients suffering from psoriasis.

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

Research has shown that guselkumab, one of the treatments in this trial, effectively treats psoriasis. In one study, nearly 6 out of 10 patients experienced skin that was 90% clearer after 16 weeks of treatment. Another study found that 64% of patients saw significant improvement in their skin condition. Guselkumab works by blocking a molecule called IL-23, which plays a key role in causing inflammation. The FDA has also approved it for treating certain types of psoriasis and psoriatic arthritis, demonstrating its effectiveness. Participants in this trial may receive guselkumab with topicals, while others may receive a placebo with topicals or continue with standard-of-care therapy. ^{2 3 4 5 6}

Who Is on the Research Team?

Jose Scher, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults with psoriasis for over 2 years, a body surface area affected by psoriasis greater than 3%, and specific ultrasound findings are eligible. They must be able to consent and not have other joint conditions, active cancer, signs of inflammatory joint issues, or be on certain immune-suppressing drugs.

Inclusion Criteria

I have been diagnosed with psoriasis by a dermatologist for at least 2 years.

I have had psoriasis for over 2 years, it covers more than 3% of my body, and my ultrasound score is over 3.36.

I have had psoriasis for over 2 years, it covers more than 3% of my body, and my ultrasound score is over 3.36.

Exclusion Criteria

I have joint pain, swelling at tendon attachment sites, or sausage-like swelling in fingers or toes.

I do not have an active infection or untreated latent TB.

I have moderate to high levels of rheumatoid arthritis markers.

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 with standard of care for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Long-term follow-up

Participants are monitored for the emergence of synovio-enthesial phenotype and transition to PsA

Year 2

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab
• Placebo

Trial Overview The trial is testing Guselkumab against a placebo in high-risk psoriasis patients across multiple centers in North America. It aims to see if the drug can reduce musculoskeletal ultrasound abnormalities and prevent arthritis linked to psoriasis after two years.

How Is the Trial Designed?

Group I: Guselkumab + Topicals (GUS) Experimental Treatment 1 Intervention

Group II: Standard-of-Care Therapy (SOC) Active Control 1 Intervention

In this third, non-randomized arm, patients would continue treatment with topical therapy or UVB, as part of our ongoing natural history of disease registries. This arm will include participants fulfilling RM-PsASon criteria but also those that do not (to serve as "negative" controls).

Group III: Placebo + Topicals (PBO) Placebo Group 2 Interventions

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?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

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

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

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

TREMFYA® Study Results 90% CLEARER SKIN ACROSS ALL SKIN TONES. In another study across all skin tones,* nearly 6 out of 10 patients saw 90% clearer skin at 16 weeks. Results may ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12199185/

Guselkumab for Moderate to Severe Scalp Psoriasis Across ... In this randomized clinical trial, after 3 doses of guselkumab, most participants achieved significant scalp clearance and clinically meaningful ...

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. 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 ... Safety data through Week 16 showed that 42% of patients receiving guselkumab and 68% of patients receiving placebo reported adverse events (AEs) ...

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906417/

Long-Term Safety of Guselkumab in Patients with Psoriatic ... Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic ...