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Investigating vilobelimab for treating ulcerative pyoderma gangrenosum

A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum

Phase 3 Interventional InflaRx GmbH · NCT05964413

This study is testing if vilobelimab can help people with ulcerative pyoderma gangrenosum heal their ulcers and feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorInflaRx GmbH Industry-sponsored
Drugs / interventionsvilobelimab, prednisone
Locations50 sites (Hialeah, Florida and 49 other locations)
Trial IDNCT05964413 on ClinicalTrials.gov

What this trial studies

This phase III trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of vilobelimab in patients with ulcerative pyoderma gangrenosum. Participants will be assessed based on their clinical diagnosis and the severity of their condition, measured using the PARACELSUS score. The trial aims to determine whether vilobelimab can effectively reduce the symptoms and improve the healing of pyoderma gangrenosum ulcers compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of ulcerative pyoderma gangrenosum and at least one evaluable ulcer.

Not a fit: Patients with target ulcers larger than 80 cm² or those with ulcers in transplanted skin may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes and quality of life for patients suffering from ulcerative pyoderma gangrenosum.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating other inflammatory skin conditions with targeted therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion Criteria:

1. 18 years or older at the time of signing the informed consent.
2. Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer, Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case of PARACELSUS score \< 10, additional justification shall be provided by the investigator to support clinical diagnosis of ulcerative PG.
3. Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of ≥ 5 cm 2 at screening and baseline

   * circulated by intact skin
   * evaluable by at least 2-dimensional measurement

Main Exclusion Criteria:

1. Patients with target ulcers exceeding 80 cm 2 .
2. Patients with target ulcer in transplanted skin.
3. Surgical wound debridement or negative pressure wound therapy (NPWT) for the target ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).
4. Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
5. Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
6. Any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of treatment with IMP).
7. Patients received any systemic medical treatment for PG within 4 weeks prior to baseline
8. Patients received any biological or immunomodulatory therapy for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP), except existing biologic or immunomodulatory therapy used for an underlying disease (other than PG at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening this is allowed to be continued.
9. 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).

Where this trial is running

Hialeah, Florida and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pyoderma Gangrenosum
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.