What is the mechanism of action of this treatment?

Common treatments for Plaque Psoriasis target specific pathways and molecules involved in the disease's pathogenesis, such as cytokines TNF-alpha, IL-17, and IL-23. TNF-alpha inhibitors (e.g., infliximab, adalimumab) block the activity of TNF-alpha to reduce inflammation. IL-17 inhibitors (e.g., secukinumab, ixekizumab) and IL-23 inhibitors (e.g., guselkumab) target these interleukins to disrupt the inflammatory cascade. These treatments are essential for patients as they address the underlying immune mechanisms, leading to reduced symptoms and improved quality of life.

What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, such as TNF-alpha inhibitors (e.g., etanercept, adalimumab), IL-12/23 inhibitors (e.g., ustekinumab), and IL-17 inhibitors (e.g., secukinumab, ixekizumab), are generally effective but come with potential side effects. TNF-alpha inhibitors can increase the risk of infections, including tuberculosis, and may be associated with a higher risk of cardiovascular events. IL-12/23 inhibitors like ustekinumab have been linked to an increased risk of infections and potential cardiovascular concerns. IL-17 inhibitors can cause mucocutaneous candidiasis and have been associated with inflammatory bowel disease exacerbations. Systemic therapies like methotrexate and cyclosporine can lead to liver toxicity, renal impairment, and hypertension. It is crucial for patients to discuss these 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 specific pathways involved in the disease's pathogenesis. TNF-alpha inhibitors like etanercept, infliximab, and adalimumab have been shown to reduce inflammation and improve symptoms. IL-12/23 inhibitors such as ustekinumab target cytokines involved in the inflammatory process. IL-17 inhibitors, including secukinumab and ixekizumab, also play a significant role in managing moderate-to-severe plaque psoriasis by targeting specific interleukins. These treatments are similar to LY3972406, which is being studied for its efficacy and safety in targeting specific immune pathways in psoriasis.

What other types of research exist?

Promising novel alternatives to LY3972406 for plaque psoriasis include: <ol> <li>IL-23 inhibitors such as guselkumab and tildrakizumab, which target the IL-23/Th17 axis.</li> <li></li> </ol> IL-17 inhibitors like secukinumab and ixekizumab, which inhibit IL-17A. 3. Dual IL-17A and IL-17F inhibitor bimekizumab. 4. TNF-alpha inhibitors such as adalimumab and etanercept, which have shown cardiovascular benefits. These treatments have demonstrated efficacy and safety in clinical trials and target key cytokines involved in psoriasis pathogenesis.

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Monoclonal Antibodies

LY3972406 for Psoriasis

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Are able to swallow oral medication

Be older than 18 years old

Must not have

Have a current or recent acute, active infection

Have any other skin conditions, excluding plaque psoriasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called LY3972406 to see if it can help adults with moderate-to-severe plaque psoriasis. The goal is to find out if it works well and is safe to use. Plaque psoriasis causes red, scaly patches on the skin, and this medication aims to reduce these symptoms.

Who is the study for?

This trial is for adults who've had moderate-to-severe chronic plaque psoriasis for at least 6 months. Participants must be able to swallow pills, allow blood sampling, and agree to skin biopsies. It's not open to those with other skin conditions or autoimmune diseases, active infections, or women who are breastfeeding.

What is being tested?

The study is testing the effectiveness and safety of a new medication called LY3972406 compared to a placebo in treating plaque psoriasis. Participants will randomly receive either the actual drug or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects of LY3972406 aren't listed here, common side effects from medications treating psoriasis may include irritation at the application site, headaches, fatigue, nausea and potential impacts on liver function.

Eligibility Criteria

Inclusion Criteria

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

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I can take pills by mouth.

Exclusion Criteria

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

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I currently have or recently had a serious infection.

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I have a skin condition other than plaque psoriasis.

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I have an autoimmune disease like lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3972406 Dose 2Experimental Treatment1 Intervention

Participants will receive an oral dose of LY3972406

Group II: LY3972406 Dose 1Experimental Treatment1 Intervention

Participants will receive an oral dose of LY3972406

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

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 Plaque Psoriasis target specific pathways and molecules involved in the disease's pathogenesis, such as cytokines TNF-alpha, IL-17, and IL-23. TNF-alpha inhibitors (e.g., infliximab, adalimumab) block the activity of TNF-alpha to reduce inflammation. IL-17 inhibitors (e.g., secukinumab, ixekizumab) and IL-23 inhibitors (e.g., guselkumab) target these interleukins to disrupt the inflammatory cascade. These treatments are essential for patients as they address the underlying immune mechanisms, leading to reduced symptoms and improved quality of life.

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