What side effects are associated with this type of intervention?

Common treatments for moderate to severe Hidradenitis Suppurativa include biologics like adalimumab, antibiotics, and systemic therapies such as zinc gluconate. Biologics can cause side effects like injection site reactions, increased risk of infections, and potential development of antibodies against the drug. Antibiotics may lead to gastrointestinal upset, antibiotic resistance, and allergic reactions. Zinc gluconate, while generally well-tolerated, can cause gastrointestinal discomfort and may interfere with copper absorption, leading to deficiencies.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa, including biologics like adalimumab (Humira), which targets tumor necrosis factor (TNF). Adalimumab is the first and only FDA-approved biologic for HS, aimed at reducing inflammation and preventing flare-ups. Other treatments, though not specifically approved for HS, include antibiotics, corticosteroids, and surgical interventions, which are used to manage symptoms and complications of the disease.

What other types of research exist?

Promising novel alternatives to Eltrekibart for Hidradenitis Suppurativa patients include: 1) Adalimumab, a TNF-alpha inhibitor, which is currently the only FDA-approved biologic for HS. 2) Secukinumab, an IL-17A inhibitor, which has shown efficacy in other inflammatory skin conditions and is being investigated for HS. 3) Guselkumab, an IL-23 inhibitor, which has demonstrated positive results in psoriasis and may offer benefits for HS. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

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Monoclonal Antibodies

Eltrekibart for Hidradenitis Suppurativa

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

Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.

Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

Must not have

Have an active skin disease or condition, that could interfere with the assessment of HS.

Have a current or recent acute, active infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called eltrekibart to find the most effective treatment for adults with moderate-to-severe hidradenitis suppurativa. The goal is to see if it can safely and effectively reduce symptoms by targeting inflammation pathways.

Who is the study for?

Adults with moderate-to-severe hidradenitis suppurativa (HS) for at least a year, lesions in two areas with one being Hurley Stage II/III, and an inadequate response to oral antibiotics can join. Those with over 20 draining fistulae, recent HS surgery, other skin conditions that could affect HS assessment, active infections or compromised immunity cannot participate.

What is being tested?

The trial is testing Eltrekibart's safety and effective dose against a placebo in adults with HS. Participants will be randomly assigned to receive either the drug or placebo for about 62 weeks across potentially 31 visits to determine the best dosage frequency for further studies.

What are the potential side effects?

While specific side effects of Eltrekibart are not listed here, common side effects from similar treatments may include skin reactions at injection sites, potential allergic responses, fatigue, headache and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

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

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I have HS lesions in 2 different body areas, with at least one being moderate to severe.

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I did not improve or couldn't tolerate a month-long course of antibiotics.

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I agree to use skin cleaners daily.

Exclusion Criteria

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

Select...

I have a skin condition that might affect HS assessment.

Select...

I currently have or recently had a serious infection.

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

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Eltrekibart Dose 3Experimental Treatment1 Intervention

Eltrekibart will be given SC.

Group II: Eltrekibart Dose 2Experimental Treatment1 Intervention

Eltrekibart will be given SC.

Group III: Eltrekibart Dose 1Experimental Treatment1 Intervention

Eltrekibart will be given subcutaneously (SC).

Group IV: PlaceboPlacebo Group1 Intervention

Placebo will be given.

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

Common treatments for Hidradenitis Suppurativa (HS) often target inflammation and immune response, which are central to the disease's pathogenesis. Biologic agents like TNF-alpha inhibitors (e.g., adalimumab) block specific inflammatory pathways, reducing chronic inflammation and immune overactivity. Zinc gluconate may enhance innate immune responses and reduce inflammation. Systemic antibiotics help by lowering bacterial load and inflammation. Understanding these mechanisms is crucial for HS patients as it aids in selecting treatments that address the underlying causes of their symptoms, potentially leading to better management and improved quality of life.