Guselkumab for Scalp Psoriasis

Overseen By Raymond Cho, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Systemic immunosuppressives

Disqualifiers: Pregnancy, Severe immunodeficiency, Tuberculosis, 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: 9 months

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not taken systemic immunosuppressives (medications that suppress the immune system) in the last 4 weeks. If you are on such medications, you may need to stop them before participating.

What data supports the effectiveness of the drug Guselkumab for treating scalp psoriasis?

Guselkumab has been shown to be effective in treating moderate-to-severe plaque psoriasis, with studies indicating it works better than some other treatments and maintains its benefits over time. It improves patients' quality of life and is generally well tolerated. ^{1 2 3 4 5}

Is Guselkumab safe for humans?

Guselkumab, also known as Tremfya, has been generally well tolerated in clinical trials for moderate-to-severe plaque psoriasis, with safety data supported by real-world studies and the FDA adverse event reporting system. ^{1 2 6 7 8}

How is the drug Guselkumab unique for treating scalp psoriasis?

Guselkumab is unique because it specifically targets and blocks interleukin-23 (IL-23), a protein involved in the inflammation process of psoriasis, making it the first drug of its kind approved for moderate-to-severe plaque psoriasis. It is administered through a subcutaneous injection and has shown superior efficacy compared to other treatments like adalimumab, with long-lasting benefits and a good safety profile. ^{1 2 9 10 11}

What is the purpose of this trial?

This trial studies how Guselkumab, a medication for psoriasis, affects immune cells in patients with moderate to severe scalp psoriasis. Guselkumab works by blocking a protein to reduce inflammation and symptoms.

Research Team

Raymond Cho, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals with moderate to severe scalp psoriasis, indicated by a PSSI score of 12 or higher. It's not suitable for those who've used systemic immunosuppressives recently, are pregnant or breastfeeding, have severe immune deficiencies, active serious infections like tuberculosis, any current cancers, or men trying to conceive.

Inclusion Criteria

Your psoriasis on your scalp is very severe.

Exclusion Criteria

I have a severe immune system problem.

I do not have tuberculosis or any serious infection.

I have not taken any immunosuppressive drugs in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Guselkumab treatment for scalp psoriasis

9 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Guselkumab

Trial Overview The study focuses on Guselkumab and its effects on the immune cells in scalp psoriasis lesions. Specifically, it looks at how blocking IL-23 with this medication influences the condition.

Participant Groups

Group I: Guselkumab treatment Experimental Treatment 1 Intervention

Guselkumab treatment for \~ 9 months

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 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 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 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, evaluated in a pooled analysis of 2891 patients over up to 5 years, showed a favorable safety profile, with adverse event rates comparable to placebo during the initial 16-week period and lower rates in the long-term follow-up.

The incidence of serious adverse events, infections, and other safety concerns remained low and consistent throughout the treatment duration, indicating that guselkumab is a safe option for treating moderate-to-severe plaque psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses across seven clinical trials with more than 8600 patient-years of exposure. Lebwohl, MG., Merola, JF., Rowland, K., et al.[2023]

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]

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 3-year study involving 31 patients, guselkumab significantly improved psoriasis severity, with a reduction in Psoriasis Area Severity Index (PASI) from 16.4 to 0.6 and Body Surface Area (BSA) from 33.2 to 1.9, indicating its long-term efficacy in managing plaque psoriasis.

The safety profile of guselkumab was favorable, with no serious adverse events reported, and only mild side effects like pharyngitis and headaches, which did not lead to treatment discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study. Megna, M., Potestio, L., Fabbrocini, G., et al.[2022]

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, specifically targeting the IL-23/IL-17 pathway, with strong safety and efficacy demonstrated in Phase II and III clinical trials.

As the first IL-23 specific inhibitor approved for this condition, guselkumab may provide advantages over existing therapies, including improved safety and less frequent administration, although long-term safety data is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab for the treatment of moderate-to-severe plaque psoriasis. Yang, EJ., Sanchez, IM., Beck, K., et al.[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]

In a study of 87 patients with moderate to severe psoriasis treated with guselkumab for up to 76 weeks, significant improvements were observed in disease severity, with 90.3% achieving at least a 75% reduction in psoriasis area and severity index (PASI) after 52 weeks.

Guselkumab demonstrated a high overall survival rate of 94% after nearly 94 weeks, indicating a good safety profile, with only four patients discontinuing treatment due to adverse events or lack of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: Mid-term effectiveness, drug survival, and safety in real clinical practice. Ruiz-Villaverde, R., Rodriguez-Fernandez-Freire, L., Armario-Hita, JC., et al.[2021]

References

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

Guselkumab: First Global Approval. [2019]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses across seven clinical trials with more than 8600 patient-years of exposure. [2023]

4. 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]

5. 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]

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

Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study. [2022]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Guselkumab for the treatment of moderate-to-severe plaque psoriasis. [2019]

10. England pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Guselkumab: Mid-term effectiveness, drug survival, and safety in real clinical practice. [2021]