What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, particularly biologics like guselkumab (an IL-23 inhibitor), often have side effects that include increased risk of infections, injection site reactions, and potential for allergic reactions. TNF-alpha inhibitors, another class of biologics, can also lead to similar side effects, including a higher risk of serious infections and potential cardiovascular events. Other biologics targeting IL-17 or IL-12/23 pathways may also cause gastrointestinal issues and increased susceptibility to infections. It is important for patients to discuss these potential risks with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for plaque psoriasis that target interleukin pathways to reduce inflammation. Guselkumab, which targets IL-23, is one such treatment. Other similar FDA-approved drugs include Ustekinumab, which targets both IL-12 and IL-23, and Risankizumab, which also targets IL-23. These treatments have shown efficacy in reducing the symptoms of moderate-to-severe plaque psoriasis in various clinical trials. Additionally, Secukinumab and Ixekizumab, which target IL-17A, have been approved and are used to treat plaque psoriasis by reducing inflammation through a different but related pathway.

What other types of research exist?

Promising novel alternatives to Guselkumab for Plaque Psoriasis include Bimekizumab, which targets IL-17A and IL-17F, and Risankizumab, which targets IL-23. Both have shown efficacy in recent clinical trials. Additionally, Secukinumab and Ixekizumab, which target IL-17A, are also effective options.

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Monoclonal Antibodies

Guselkumab for Plaque Psoriasis (SPECTREM Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must meet specific disease severity criteria at screening and at baseline

Participants must be inadequately controlled with or intolerant of at least 1 prior topical therapy for the treatment of psoriasis at both screening

Must not have

Has a history of chronic or recurrent infectious disease

Has current drug-induced psoriasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 56

Awards & highlights

Pivotal Trial

Summary

This trial is testing guselkumab, a medication that targets the immune system, on people with moderate plaque psoriasis affecting small areas and special sites. The drug helps reduce inflammation and rapid skin cell growth. Guselkumab has been approved for the treatment of moderate-to-severe plaque psoriasis.

Who is the study for?

This trial is for individuals with a diagnosis of moderate plaque psoriasis covering a low area of the body, who haven't responded well to or can't tolerate at least one topical treatment. They should be eligible for light therapy or systemic treatment and have had psoriasis for over six months. People with non-plaque psoriasis, drug-induced psoriasis, certain palmoplantar conditions, previous biologic treatments, or chronic infections cannot participate.

What is being tested?

The study aims to compare the effectiveness of Guselkumab (a medication) against a placebo (an inactive substance) in treating patients with moderate plaque psoriasis affecting small areas of their body including special sites like palms and soles.

What are the potential side effects?

Guselkumab may cause side effects such as injection site reactions, upper respiratory infections, headache, and possibly serious but rare events like severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition meets the required severity criteria.

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My psoriasis hasn't improved with at least one skin treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of chronic or recurring infections.

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I have psoriasis caused by medication.

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My psoriasis is not in the form of plaques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

Secondary study objectives

Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16

Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16

Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.

Group II: Group 2: PlaceboPlacebo Group2 Interventions

Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Plaque Psoriasis treatments often target specific pathways in the immune system to reduce inflammation and slow down the rapid skin cell turnover characteristic of the disease. Guselkumab, for example, is a monoclonal antibody that targets the IL-23p19 subunit, inhibiting the IL-23 pathway, which is crucial in the inflammatory process of psoriasis. Other treatments include TNF-alpha inhibitors, which block the tumor necrosis factor-alpha, a cytokine involved in systemic inflammation, and IL-17 inhibitors, which target the IL-17 pathway, another key player in psoriasis-related inflammation. These treatments are significant for patients as they help manage symptoms, reduce flare-ups, and improve quality of life by addressing the underlying inflammatory processes of Plaque Psoriasis.

Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced.Targeting IL-23 in psoriasis: current perspectives.