What side effects are associated with this type of intervention?

Common treatments for pustular psoriasis, particularly biologic agents, have a range of side effects. TNF-alpha inhibitors like infliximab and adalimumab can cause infections, injection site reactions, and in some cases, autoimmune conditions. IL-17 inhibitors such as secukinumab and ixekizumab are associated with increased risk of infections, inflammatory bowel disease, and injection site reactions. IL-23 inhibitors like ustekinumab and guselkumab may lead to infections, headache, and injection site reactions. These side effects are important to consider when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

For the treatment of generalized pustular psoriasis, the FDA has approved several systemic therapies. Infliximab, a TNF-alpha inhibitor, and methotrexate, an immunosuppressant, have shown efficacy in achieving long-term remission. Additionally, Imsidolimab, an anti-IL-36 receptor antibody, is currently being studied in clinical trials for its potential benefits in treating this condition. These treatments target specific immune pathways involved in the inflammatory process of pustular psoriasis.

What other types of research exist?

Promising novel alternatives to Imsidolimab for pustular psoriasis patients include Adalimumab (a TNF-α inhibitor), Secukinumab (an IL-17A inhibitor), and Risankizumab (an IL-23 inhibitor). These treatments have shown efficacy in cases where other therapies have failed, making them viable options for consideration in 2024.

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Monoclonal Antibodies

Imsidolimab for Generalized Pustular Psoriasis (GEMINI-2 Trial)

Phase 3

Waitlist Available

Research Sponsored by AnaptysBio, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called imsidolimab to see if it can help adults with a severe skin condition called generalized pustular psoriasis. The medication works by blocking certain proteins that cause inflammation and skin problems. Imsidolimab has shown promising results for treating pustular psoriasis.

Who is the study for?

This trial is for adults with generalized pustular psoriasis who completed at least the first week of a previous Phase 3 study without using any rescue or prohibited medications. Candidates must be deemed in need of long-term treatment by the investigator.

What is being tested?

The trial is testing the long-term safety and effectiveness of Imsidolimab, an investigational drug, against a placebo in managing symptoms and flare-ups associated with generalized pustular psoriasis.

What are the potential side effects?

While specific side effects are not listed here, common side effects for drugs treating psoriasis may include skin irritation, headaches, fatigue, nausea, and potential immune system changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Awards & Highlights

Pivotal Trial

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

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: SC ImsidolimabActive Control1 Intervention

Subcutaneous Imsidolimab

Group II: IV +SC ImsidolimabActive Control1 Intervention

IV loading dose followed by subcutaneous Imsidolimab

Group III: Standard of CareActive Control1 Intervention

Any available therapy

Group IV: SC PlaceboPlacebo Group1 Intervention

Subcutaneous Placebo

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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

The most common treatments for Pustular Psoriasis often involve biologic agents that target specific interleukin pathways, such as IL-17, IL-23, and IL-36. These treatments work by inhibiting the activity of these cytokines, which are key drivers of the inflammatory process in psoriasis. For instance, IL-17 and IL-23 inhibitors reduce the proliferation of keratinocytes and the infiltration of inflammatory cells in the skin. Imsidolimab, an Anti-IL-36 Receptor Antibody, specifically targets the IL-36 pathway, which is implicated in the pathogenesis of pustular psoriasis by promoting inflammation and pustule formation. Understanding these mechanisms is crucial for patients as it helps in selecting targeted therapies that can effectively manage their symptoms and improve their quality of life.