What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include antibiotics, anti-TNF therapies, and hormonal treatments. Known side effects of these treatments can include gastrointestinal issues, increased risk of infections, and potential liver toxicity. For IL-1 inhibitors like Lutikizumab (ABT-981), side effects may include injection site reactions, upper respiratory infections, headache, and fatigue. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa (HS), primarily focusing on biologic therapies. The most notable FDA-approved drug for HS is Adalimumab, a TNF inhibitor, marketed under the brand name Humira. It is used for moderate to severe cases of HS. While Lutikizumab (ABT-981) is an investigational IL-1 inhibitor, there are currently no FDA-approved IL-1 inhibitors specifically for HS. Other treatments for HS include antibiotics, hormonal therapy, and surgical interventions, but these are not biologic therapies like Lutikizumab.

What other types of research exist?

Promising, novel alternatives to Lutikizumab (ABT-981) for Hidradenitis Suppurativa patients in 2024 may include other biologic agents such as IL-17 inhibitors (e.g., Secukinumab) and JAK inhibitors (e.g., Upadacitinib). These agents target different inflammatory pathways and have shown efficacy in treating other inflammatory skin conditions.

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Monoclonal Antibodies

Lutikizumab for Hidradenitis Suppurativa

Phase 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Must have failed anti-TNF treatment for HS

HS lesions present in at least 2 distinct anatomic areas

Must not have

History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately week 68

Summary

This trial is testing a new drug called lutikizumab to help adults with a painful skin condition called hidradenitis suppurativa (HS) who haven't been helped by other treatments. The drug works by reducing inflammation in the skin.

Who is the study for?

Adults with moderate to severe Hidradenitis Suppurativa (HS) who didn't get better with anti-TNF therapy can join. They must have at least 5 abscesses and nodules in two different body areas, been diagnosed with HS for a year or more, and not tried biologic treatments yet.

What is being tested?

The trial is testing Lutikizumab (ABT-981), an experimental drug, against a placebo. Participants will be randomly assigned to receive either the drug or placebo through weekly injections for up to 16 weeks in the main study, and possibly longer in a sub-study.

What are the potential side effects?

Possible side effects of Lutikizumab are not detailed here but may include reactions at the injection site, increased risk of infections due to immune system suppression, and other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have tried anti-TNF treatment for HS without success.

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I have HS lesions in at least two different body areas.

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I have not used biologic therapy for my HS condition.

Exclusion Criteria

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

Select...

I have no active skin conditions that could affect HS assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately week 68

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately week 68

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately week 68 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with Adverse Events (AEs)

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)

Secondary study objectives

Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Sub-study: Group 2Experimental Treatment1 Intervention

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

Group II: Sub-study: Group 1Experimental Treatment1 Intervention

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.

Group III: Main Study: Lutikizumab Dose CExperimental Treatment1 Intervention

Lutikizumab Dose C every other week

Group IV: Main Study: Lutikizumab Dose BExperimental Treatment1 Intervention

Lutikizumab Dose B every other week

Group V: Main Study: Lutikizumab Dose AExperimental Treatment1 Intervention

Lutikizumab Dose A every week

Group VI: Main Study: PlaceboPlacebo Group1 Intervention

Placebo every week

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

Hidradenitis Suppurativa (HS) is primarily driven by chronic inflammation, often involving the dysregulation of cytokines such as TNF-alpha and IL-1. Common treatments include anti-TNF therapies like adalimumab, which block TNF-alpha to reduce inflammation and immune response. Lutikizumab (ABT-981), an IL-1 inhibitor, targets the IL-1 pathway, which is crucial in the inflammatory process of HS. By inhibiting IL-1, Lutikizumab aims to reduce the formation of painful lumps, abscesses, and scarring. Understanding these mechanisms is vital for HS patients as it helps in selecting targeted therapies that can effectively manage symptoms and improve quality of life.