What side effects are associated with this type of intervention?

Common treatments for scalp psoriasis, particularly IL-23 inhibitors like Guselkumab, include biologics such as secukinumab (IL-17 inhibitor) and ixekizumab (IL-17 inhibitor). Known side effects of these treatments can include upper respiratory infections, injection site reactions, and headache. More serious but less common side effects may involve increased risk of infections, exacerbation of inflammatory bowel disease, and potential allergic reactions. It is important for patients to discuss these risks with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for scalp psoriasis that are similar to Guselkumab, which targets IL-23, include other biologics that target specific interleukins involved in the inflammatory process. Secukinumab and Ixekizumab, both IL-17 inhibitors, have shown efficacy in treating moderate to severe plaque psoriasis, including scalp involvement. These drugs work by inhibiting the activity of IL-17A, a cytokine that plays a crucial role in the pathogenesis of psoriasis. Additionally, other IL-23 inhibitors like Tildrakizumab and Risankizumab have also been approved for the treatment of moderate to severe plaque psoriasis, offering targeted therapy options for patients.

What other types of research exist?

Promising alternatives to Guselkumab for scalp psoriasis include Secukinumab and Ixekizumab, both of which are IL-17 inhibitors. These treatments have demonstrated efficacy in various forms of psoriasis, including scalp psoriasis, and have been supported by recent clinical trials.

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Monoclonal Antibodies

Guselkumab for Scalp Psoriasis

Phase 4

Recruiting

Led By Raymond Cho, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Severe immunodeficiency (either from genetic or infectious causes)

Tuberculosis or other active serious infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 9 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Guselkumab may cause side effects such as injection site reactions (like pain or swelling), headaches, joint pain, stomach issues and potential increased risk of infections due to its impact on the immune system.

Eligibility Criteria

Exclusion Criteria

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

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I have a severe immune system problem.

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I do not have tuberculosis or any serious infection.

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I have an active cancer that is affecting my whole body.

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I am a male trying to have a child.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 9 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in psoriasis scalp severity index score (PSSI)

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Awards & Highlights

Pivotal Trial

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Guselkumab treatmentExperimental Treatment1 Intervention

Guselkumab treatment for \~ 9 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

0 / 4Eligibility 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

Common treatments for scalp psoriasis include topical corticosteroids, vitamin D analogs, and biologics like IL-23 inhibitors. Guselkumab, an IL-23 blocker, works by targeting the IL-23 cytokine, which plays a crucial role in the inflammatory process of psoriasis. By inhibiting IL-23, Guselkumab reduces the activation and proliferation of T-cells that contribute to the psoriatic plaques. Understanding these mechanisms is important for patients as it helps them comprehend how these treatments can effectively reduce inflammation and improve symptoms, leading to better management of their condition.