What side effects are associated with this type of intervention?

Common treatments for Pyoderma Gangrenosum, particularly those involving biologics and monoclonal antibodies like Spesolimab, often have side effects that include injection site reactions (e.g., erythema, pain, or bruising), hypersensitivity reactions (e.g., rash, pruritus, urticaria), and potential immunologic effects such as the development of drug-neutralizing antibodies. Serious allergic reactions, though rare, can occur and may include severe urticaria and hypersensitivity vasculitis. Additionally, there may be a small risk of neurocognitive symptoms and infections due to immunosuppression.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Pyoderma Gangrenosum in the provided context. Spesolimab, an Anti-IL-36 Receptor Antibody, is currently being studied for its feasibility in treating this condition. Broadly, treatments for Pyoderma Gangrenosum often involve immunosuppressive therapies, but specific FDA-approved drugs for this condition are not detailed in the provided information.

What other types of research exist?

Promising alternatives to Spesolimab for Pyoderma Gangrenosum patients include Apremilast (a phosphodiesterase 4 inhibitor) and Tofacitinib (a Janus kinase inhibitor). Both have shown potential in treating other inflammatory and autoimmune conditions and may offer new therapeutic options for PG.

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Monoclonal Antibodies

Spesolimab for Pyoderma Gangrenosum

Phase 2

Recruiting

Led By Saakshi Khattri, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Subject has moderate to severe PG as determined by a GPG severity score of >3

Male or female subjects ≥ 18 years of age at the time of signing the informed consent document

Must not have

Subject with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e. Common Variable Immunodeficiency [CVID]), hepatitis B or C, or active or untreated latent tuberculosis

Subject has presence of acute demyelinating neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up last dose (week 26 or 28) up to 16 week post-spesolimab last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing spesolimab, a medicine that blocks inflammation signals, in patients with severe skin ulcers caused by pyoderma gangrenosum. These patients often suffer from pain and have no standard treatment options. Spesolimab aims to reduce inflammation and help heal their skin ulcers.

Who is the study for?

Adults with moderate to severe pyoderma gangrenosum, a skin ulcer condition, who haven't responded to treatments like steroids or other immune therapies. Participants must be in good health otherwise and women of childbearing age must use effective contraception.

What is being tested?

The trial is testing spesolimab's effectiveness on pyoderma gangrenosum by observing changes in the body's immune response and improvement in skin ulcers.

What are the potential side effects?

Potential side effects may include reactions related to the immune system since spesolimab targets specific pathways involved in inflammation. Exact side effects are not listed but could resemble those of other immunotherapies.

Eligibility Criteria

Inclusion Criteria

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

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My gum disease is moderate to severe, with a score over 3.

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I am 18 years or older and can consent to participate.

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I have a severe type of skin ulcer.

Exclusion Criteria

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

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I have or had HIV, immunodeficiency, hepatitis B or C, or tuberculosis.

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I have a condition where my nerves are damaged by my immune system.

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I have been treated with spesolimab or a similar medication before.

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I have not had major surgery in the last 12 weeks and do not plan any during the trial.

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I have or might have a type of blood cancer.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ last dose (week 26 or 28) up to 16 week post-spesolimab last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~last dose (week 26 or 28) up to 16 week post-spesolimab last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and last dose (week 26 or 28) up to 16 week post-spesolimab last dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Global Pyoderma Gangrenosum (GPG) Severity Score

Secondary study objectives

Absolute Change in Dermatology Life Quality Index (DLQI)

Absolute Change in patient-reported Pain severity (Pain-VAS) score

Number of participants with Complete re-epithelization of PG lesions

+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: SpesolimabExperimental Treatment1 Intervention

900 mg of spesolimab intravenously (IV)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spesolimab

2016

Completed Phase 3

~650

0 / 9Eligibility 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

The most common treatments for Pyoderma Gangrenosum (PG) involve immunosuppressive agents that reduce inflammation by broadly suppressing the immune system. These include corticosteroids, cyclosporine, and TNF-alpha inhibitors. Spesolimab, an anti-IL-36 receptor antibody, represents a more targeted approach by inhibiting the IL-36 pathway, which plays a crucial role in the inflammatory response in PG. This targeted therapy is significant for PG patients as it aims to directly address the underlying immune dysregulation, potentially offering improved efficacy and reduced side effects compared to broader immunosuppressive treatments.

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