Subcutaneous Guselkumab for Psoriasis

(PROTOSTAR Trial)

Recruiting at 46 trial locations

Overseen By Study Contact

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Beta blockers, Calcium channel blockers, Lithium

Disqualifiers: Nonplaque psoriasis, Chronic infections, Lymphoproliferative disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called guselkumab to see if it is safe and effective for children and teenagers with chronic plaque psoriasis. The medication aims to reduce inflammation and slow down the rapid growth of skin cells. Guselkumab is the first IL-23 specific inhibitor to be approved for the treatment of plaque psoriasis and has shown excellent safety and efficacy in previous studies.

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 are taking medications that cause drug-induced psoriasis, you may not be eligible to participate.

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

Guselkumab has been shown to be effective in treating moderate-to-severe plaque psoriasis, with clinical trials demonstrating significant improvements in skin condition and quality of life compared to placebo and other treatments like adalimumab. In the VOYAGE trials, a higher percentage of patients achieved clear or almost clear skin with Guselkumab, and these benefits were maintained for up to two years. ^{1 2 3 4 5}

Is guselkumab safe for humans?

Guselkumab, used for treating moderate-to-severe plaque psoriasis, is generally well tolerated according to clinical trials and real-world studies. Some adverse events have been reported, but it is considered a safe option for patients. ^{1 2 6 7 8}

What makes the drug Guselkumab unique for treating psoriasis?

Guselkumab is unique because it is the first drug in its class to selectively block the interleukin-23 (IL-23) pathway, which is involved in the immune response that causes psoriasis. It is administered as a subcutaneous injection and has shown superior effectiveness compared to other treatments like adalimumab, with long-lasting benefits and improvements in quality of life for patients with moderate to severe plaque psoriasis. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for children and teens aged 6 to less than 18 with chronic plaque psoriasis. They must have had the condition for at least 6 months, show certain levels of severity, be up-to-date on vaccinations or immune to varicella and MMR, and could benefit from etanercept therapy. Those with a history of lymphoproliferative disease, previous guselkumab or etanercept use, chronic infections, nonplaque psoriasis types, or drug-induced psoriasis cannot join.

Inclusion Criteria

Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator

I am immune to varicella and MMR through vaccination, past infection, or positive antibody tests.

I am eligible for light therapy or systemic treatment for plaque psoriasis.

Exclusion Criteria

I have a history of chronic or recurrent infections.

My psoriasis is not the common plaque type.

I have been treated with guselkumab or etanercept before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weight-based doses of guselkumab or placebo administered subcutaneously at specified intervals

52 weeks

Visits at Weeks 0, 4, 12, 16, 20, 24, and every 8 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long Term Extension (LTE)

Participants who are eligible and willing may continue guselkumab treatment beyond the main study period

Long-term

Treatment Details

Interventions

• Etanercept
• Guselkumab
• Placebo for Guselkumab

Trial Overview The study tests the effectiveness and safety of Guselkumab administered under the skin in young patients with plaque psoriasis compared to Etanercept (another treatment) and a placebo. The goal is to see how well Guselkumab works in reducing symptoms of this skin condition.

Participant Groups

Group I: Part 2: Guselkumab Experimental Treatment 1 Intervention

Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter.

Group II: Part 1 Group 1: Guselkumab Experimental Treatment 2 Interventions

Participants in Part 1a (age greater than or equal to (\>=) 12 - less than (\<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose \>=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.

Group III: Part 1 Group 3: Etanercept Active Control 2 Interventions

Participants in Part 1a (age \>= 12 - \<18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.

Group IV: Part 1 Group 2: Placebo for Guselkumab Placebo Group 2 Interventions

Participants in Part 1a (age \>= 12 - \<18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose \>=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

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 is an effective treatment for moderate-to-severe psoriasis, showing significant improvements in skin condition and quality of life in clinical trials, and is generally well tolerated by patients.

In head-to-head trials, guselkumab outperformed adalimumab and secukinumab in achieving higher response rates for psoriasis severity, indicating its superior efficacy in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab for the treatment of adults with moderate to severe plaque psoriasis. Puig, L.[2020]

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]

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]

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]

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

Guselkumab for the treatment of adults with moderate to severe plaque psoriasis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Rapid Remission of Sunburn-Induced Guttate Psoriasis with Guselkumab. [2023]

6. 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]

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. 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]