Guselkumab for Psoriasis

(PAMPA Trial)

Recruiting in Toronto (>99 mi)

+4 other locations

Overseen by Jose Scher, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: NYU Langone Health

Must not be taking: Immunosuppressives, Biologics

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests Guselkumab, a medication that reduces inflammation, on high-risk psoriasis patients to prevent them from developing Psoriatic Arthritis. The drug works by blocking IL-23, a molecule that causes inflammation. Guselkumab is approved for treating moderate-to-severe plaque psoriasis.

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 data supports the idea that Guselkumab for Psoriasis is an effective drug?

The available research shows that Guselkumab is effective for treating moderate to severe plaque psoriasis. In the VOYAGE trials, it was better than a placebo and another drug called adalimumab at helping patients improve their skin condition by week 16. These improvements lasted up to 2 years. In another study, patients who didn't respond well to a different drug, ustekinumab, showed better results when switched to Guselkumab. Overall, Guselkumab improved patients' quality of life and was well tolerated. ^{1 2 3 4 5}

What safety data is available for Guselkumab in treating psoriasis?

Guselkumab, also known as Tremfya, has been evaluated for safety in several studies and trials. It is generally well tolerated, with a consistent safety profile observed in up to 5 years of continuous treatment, as shown in pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials. Additionally, a meta-analysis of randomized controlled trials assessed its short-term efficacy and safety, and real-world data from the FDA adverse event reporting system has been used to characterize its adverse event profile. Overall, Guselkumab is considered a safe treatment option for moderate-to-severe plaque psoriasis. ^{1 2 3 5 6}

Is Guselkumab a promising drug for treating psoriasis?

Yes, Guselkumab is a promising drug for treating psoriasis. It has been approved in the USA and other countries for moderate-to-severe plaque psoriasis. Studies show it works better than a placebo and another drug called adalimumab, with benefits lasting up to 2 years. It also improves patients' quality of life and is generally well tolerated. ^{1 2 3 4 7}

Research Team

Jose Scher, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Guselkumab (Monoclonal Antibodies)
• Placebo (Other)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Findings from Research

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 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]

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. [2019]

3. United States 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. [2022]

4. New Zealand 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. [2021]

5. Egypt 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. [2022]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. [2021]