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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

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 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
8%
Syncope
8%
Colitis ulcerative
8%
Nasopharyngitis
4%
Anaemia
4%
Rash
4%
Infusion related reaction
4%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
300 mg Spesolimab (BI 655130) SD
1200 mg Spesolimab (BI 655130) q4w
450 mg Spesolimab (BI 655130) q4w

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
~700

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.
Sphingosine-1-Phosphate and Its Signal Modulators Alleviate Psoriasis-Like Dermatitis: Preclinical and Clinical Evidence and Possible Mechanisms.Amelioration of Compound 48/80-Mediated Itch and LL-37-Induced Inflammation by a Single-Stranded Oligonucleotide.JAK-STAT signaling pathway inhibition: a role for treatment of discoid lupus erythematosus and dermatomyositis.

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor
2,534 Previous Clinical Trials
11,357,507 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
535,023 Total Patients Enrolled
Saakshi Khattri, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
40 Total Patients Enrolled
~10 spots leftby Sep 2025
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