What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include biologics such as adalimumab and infliximab, which target TNF-alpha, and newer agents like Spesolimab, an Anti-IL-36 Receptor Antibody. Known side effects of these treatments can include injection site reactions, increased risk of infections, and potential development of antibodies against the drug, which may reduce its efficacy. Other side effects may include headache, upper respiratory infections, and gastrointestinal issues. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for Hidradenitis Suppurativa, primarily focusing on TNF inhibitors. Adalimumab (Humira) is the first and only FDA-approved biologic specifically for moderate to severe HS. It works by inhibiting tumor necrosis factor (TNF), a substance in the body that causes inflammation. Other biologics, such as infliximab, have been used off-label for HS. While Spesolimab, an anti-IL-36 receptor antibody, is currently under investigation, it represents a novel approach targeting a different inflammatory pathway compared to existing treatments.

What other types of research exist?

Promising alternatives to Spesolimab for Hidradenitis Suppurativa patients in 2024 include anti-IL-23 agents such as ustekinumab, risankizumab, and guselkumab. These biologics have shown efficacy in other inflammatory conditions and may offer new treatment options for HS.

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Monoclonal Antibodies

Long-term Spesolimab Treatment for Hidradenitis Suppurativa

Phase 2

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof

Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial involves adults with hidradenitis suppurativa who previously took part in a spesolimab study. Participants receive spesolimab injections regularly over a long period. The study aims to see if the drug is safe and effective over time by reducing inflammation and symptoms.

Who is the study for?

Adults with hidradenitis suppurativa who were in a prior spesolimab study can join. They must have finished the previous trial without early stoppage, agree to birth control if applicable, and not be planning pregnancy or major surgery. Those with severe health issues or allergies to the drug are excluded.

What is being tested?

The trial tests long-term safety and effectiveness of spesolimab for hidradenitis suppurativa over approximately 2 years and 4 months. Participants receive bi-weekly injections and undergo regular health checks to monitor their skin condition's severity.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any health problems that may arise from receiving spesolimab injections regularly over an extended period.

Eligibility Criteria

Exclusion Criteria

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

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I do not have any severe or worsening health conditions affecting my organs or mental health.

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I am not pregnant, nursing, or planning to become pregnant during the trial.

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I do not have any major surgeries planned during the trial.

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I am not allergic to the trial medication or its ingredients.

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I have no new or suspected cancers, except for treated skin cancer or cervical cancer in situ.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Hidradenitis

Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to week 12

Hidradenitis

+2 more

Side effects data

From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635

Syncope

Colitis ulcerative

Nasopharyngitis

Anaemia

Rash

Infusion related reaction

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

300 mg Spesolimab (BI 655130) SD

1200 mg Spesolimab (BI 655130) q4w

450 mg Spesolimab (BI 655130) q4w

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants from parent trial (1368-0052) who were on placebo or active medicationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spesolimab

2016

Completed Phase 3

~650

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

Hidradenitis Suppurativa (HS) treatments often target the immune system to reduce inflammation and prevent flare-ups. Spesolimab, an Anti-IL-36 Receptor Antibody, works by inhibiting the IL-36 pathway, which is involved in the inflammatory response seen in HS. This is crucial for HS patients as it helps to control the chronic inflammation and reduce the formation of painful nodules and abscesses. Other common treatments include TNF inhibitors like infliximab, which block tumor necrosis factor-alpha (TNF-α), a cytokine that promotes inflammation, and zinc gluconate, which modulates immune function and reduces inflammation. These treatments aim to manage symptoms, prevent disease progression, and improve the quality of life for HS patients.

[Hidradenitis suppurativa. Response to treatment with infliximab].