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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 16

Awards & highlights

Study Summary

This trial will study if spesolimab can help treat ulcers caused by pyoderma gangrenosum, an autoimmune skin condition, and how it affects the body's immune system.

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.Check my eligibility

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.See study design

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

Select...

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.

Select...

I have a severe type of skin ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Global Pyoderma Gangrenosum (GPG) Severity Score

Secondary outcome measures

Change in Dermatology Life Quality Index (DLQI)

Change in Pain severity (Pain-VAS) score

Number of participants with GPG Score 0

+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

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

~580

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,887 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,606 Total Patients Enrolled

Saakshi Khattri, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

2 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted authorization for Spesolimab to be used in therapeutic treatments?

"There is an established record of safety due to its status as a Phase 4 trial, so Spesolimab was assigned a score of 3."

Answered by AI

Are participants currently being accepted for this research endeavor?

"Affirmative. As indicated by the information listed on clinicaltrials.gov, this medical research is presently seeking out volunteers for participation. It first appeared online on October 1st 2023 and was last updated three weeks later; it requires a total of twenty participants from one site to complete its objectives."

Answered by AI

What is the total enrollment capacity of this research project?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking participants and was first listed on October 1st 2023 before being updated most recently on the 16th of that same month. There are a total of 20 vacancies spread across a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spesolimab in Pyoderma Gangrenosum

Saakshi Khattri 2023. "Spesolimab in Pyoderma Gangrenosum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06092216.