What side effects are associated with this type of intervention?

Common treatments for Pyoderma Gangrenosum, especially those targeting the immune system like Vilobelimab, can have side effects such as increased risk of infections, injection site reactions, and allergic reactions. Complement inhibitors may also cause hypersensitivity reactions and affect the immune system's infection response.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Pyoderma Gangrenosum that target the inhibition of complement component C5a, like Vilobelimab. Broadly, treatments for Pyoderma Gangrenosum often include systemic immunosuppressants such as corticosteroids, cyclosporine, and biologics like infliximab and adalimumab, which target different pathways in the immune system to reduce inflammation and promote healing.

What other types of research exist?

Promising novel alternatives to Vilobelimab for Pyoderma Gangrenosum patients include: <ol> <li>Rituximab: An anti-CD20 monoclonal antibody that has shown success in treating refractory cases of autoimmune blistering diseases.</li> <li>Daclizumab: A humanized anti-Tac monoclonal antibody that has been used in the treatment of refractory epidermolysis bullosa acquisita, which shares some pathophysiological features with PG.</li> <li>Extracorporeal Photopheresis (ECP): A treatment modality that has shown efficacy in severe autoimmune conditions and may be beneficial for PG.</li> <li>Janus Kinase (JAK) Inhibitors: Such as Tofacitinib, which have shown benefit in other inflammatory skin conditions and may offer a new therapeutic approach for PG.</li> </ol>

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Monoclonal Antibodies

Vilobelimab for Pyoderma Gangrenosum

Phase 3

Recruiting

Research Sponsored by InflaRx GmbH

Eligibility Criteria Checklist

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

Must have

18 years or older at the time of signing the informed consent

Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria: area of ≥ 5 cm2 at screening and baseline, circulated by intact skin, and evaluable by at least 2-dimensional measurement

Must not have

Patients received any systemic medical treatment for PG within 4 weeks prior to baseline

Patients receiving corticosteroids treatment for PG of more than 10 mg/day of prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment with IMP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 10 through study completion

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called vilobelimab to see if it can help people with a painful skin condition called ulcerative pyoderma gangrenosum. The medication works by stopping the body from making substances that cause swelling and sores. Researchers want to find out if this treatment is safe and effective for these patients.

Who is the study for?

Adults diagnosed with ulcerative pyoderma gangrenosum (PG) can join this trial. They must have a PG symptom score of 10 or more and at least one qualifying PG ulcer larger than 5 cm2. People are excluded if they've had certain treatments for PG, infections needing systemic treatment, vaccinations within two weeks before the trial starts, or previous exposure to vilobelimab.

What is being tested?

The trial is testing the effectiveness and safety of a drug called vilobelimab against a placebo in treating ulcerative pyoderma gangrenosum. Participants will be randomly assigned to receive either vilobelimab or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects for vilobelimab aren't listed here, common side effects may include reactions at the injection site, increased risk of infection due to immune system suppression, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have a skin ulcer larger than 5 cm2 that can be measured in two ways.

Exclusion Criteria

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

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I have not had any systemic treatment for PG in the last 4 weeks.

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I have been taking more than 10 mg/day of prednisone or its equivalent for the past 4 weeks.

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I haven't taken antibiotics or anti-infectives for an infection in the last 2 weeks.

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My ulcer is larger than 80 cm2.

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I have a target ulcer in my transplanted skin.

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I have previously been treated with vilobelimab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 10 through study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 10 through study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10 through study completion for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Efficacy of treatment with vilobelimab compared to placebo

Pain reduction

Side effects data

From 2022 Phase 2 trial • 19 Patients • NCT03971643

33%

Wound infection pseudomonas

33%

Wound infection

33%

Dermatitis contact

33%

Traumatic haematoma

17%

Endocarditis

17%

Cellulitis

17%

Intervertebral discitis

17%

Sepsis

17%

Pneumonia

17%

Impetigo

17%

Nasopharyngitis

17%

Actinic keratosis

17%

Urticaria

17%

Head injury

17%

Haemoglobin decreased

17%

Gingivitis

17%

Dermatitis

17%

Lichen planus

17%

Seborrhoeic dermatitis

17%

Urinary tract infection

17%

Skin laceration

17%

Glossitis

17%

Peptic ulcer

17%

Blood creatinine increased

17%

Superficial vein thrombosis

17%

Hypothyroidism

17%

Haematuria

100%

80%

60%

40%

20%

Study treatment Arm

Vilobelimab 800 mg Q2W

Vilobelimab 1600 mg Q2W

Vilobelimab 2400 mg Q2W

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: vilobelimabExperimental Treatment1 Intervention

Patients will be treated with vilobelimab IV, Q2W for 26 weeks

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive placebo IV in the same schedule as patients in Arm 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

vilobelimab

2019

Completed Phase 2

~20

0 / 8Eligibility 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

Pyoderma Gangrenosum (PG) is an inflammatory skin condition often treated by targeting the immune system to reduce inflammation. Vilobelimab, which inhibits complement component C5a, works by blocking a key part of the immune response that contributes to inflammation and tissue damage in PG. This is significant for PG patients as it directly addresses the excessive immune activation that characterizes the disease. Other common treatments include corticosteroids and immunosuppressants, which broadly dampen the immune response, and biologics like TNF-alpha inhibitors, which target specific inflammatory pathways. These treatments are crucial for managing PG as they help to control the severe inflammation and prevent further tissue damage.

Studies on complement deposits in epidermolysis bullosa acquisita and bullous pemphigoid.