What side effects are associated with this type of intervention?

Common treatments for psoriasis, particularly biologics like IL-23 inhibitors (e.g., Guselkumab) and IL-17 inhibitors (e.g., Secukinumab, Ixekizumab), can have several side effects. These may include increased risk of infections, injection site reactions, and potential exacerbation of inflammatory bowel disease. Other systemic therapies, such as methotrexate and cyclosporine, can cause liver toxicity, kidney dysfunction, and hypertension. Long-term use of these treatments requires careful monitoring to manage and mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for psoriasis that target specific components of the immune system. Guselkumab, an IL-23 inhibitor, is one such treatment, approved for moderate-to-severe plaque psoriasis. Other IL-23 inhibitors include Tildrakizumab and Risankizumab, which have also shown efficacy in treating psoriasis. Additionally, IL-17 inhibitors like Secukinumab and Ixekizumab, and TNF-alpha inhibitors such as Adalimumab and Infliximab, have been approved for psoriasis treatment. These biologics work by targeting different pathways involved in the inflammatory process of psoriasis.

What other types of research exist?

Promising novel alternatives to Guselkumab for psoriasis patients include IL-17 inhibitors like Secukinumab and Ixekizumab, IL-12/23 inhibitor Ustekinumab, and JAK inhibitors such as Tofacitinib and Upadacitinib. Additionally, Bimekizumab, which targets both IL-17A and IL-17F, has shown efficacy in recent trials and may be a viable option.

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Monoclonal Antibodies

Guselkumab for Psoriasis (PAMPA Trial)

Phase 4

Recruiting

Led By Jose Scher, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants)

18 years old or older

Must not have

Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam

Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 2

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Guselkumab may include reactions at the injection site, infections due to lowered immunity, headaches, stomach pain, and allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with psoriasis by a dermatologist for at least 2 years.

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

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

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I have joint pain, swelling at tendon attachment sites, or sausage-like swelling in fingers or toes.

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I do not have an active infection or untreated latent TB.

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I have moderate to high levels of rheumatoid arthritis markers.

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I have an active cancer.

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I am currently taking medication that suppresses my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 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 Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score

Arthritis, Psoriatic

Secondary study objectives

Achieved IGA mod 2011 Score

Change in EuroQol-5D (EQ-5D) Score

Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale

+7 more

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.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Guselkumab + Topicals (GUS)Experimental Treatment1 Intervention

Group II: Standard-of-Care Therapy (SOC)Active Control1 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 Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

0 / 8Eligibility 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

Psoriasis treatments often target specific components of the immune system to reduce inflammation and slow the overproduction of skin cells. Biologic agents, such as Guselkumab, work by inhibiting interleukin-23 (IL-23), a cytokine that plays a crucial role in the inflammatory process of psoriasis. By blocking IL-23, these treatments can significantly reduce the symptoms and progression of the disease. Other biologics target different interleukins, such as IL-17 and IL-12/23, or tumor necrosis factor-alpha (TNF-alpha), all of which are involved in the inflammatory pathways of psoriasis. Understanding these mechanisms is important for patients as it helps them comprehend how these treatments can effectively manage their condition and improve their quality of life.