A Phase 3 interventional study of vilobelimab and Placebo in Pyoderma Gangrenosum, sponsored by InflaRx GmbH. Terminated at 50 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by InflaRx GmbH · Phase 3, Interventional, and Treatment
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
36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.
This study's enrollment of 54 is above the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.
Browse Pyoderma Gangrenosum studies →InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
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
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
Drug: vilobelimab
Patients will receive placebo IV in the same schedule as patients in Arm 1
Drug: Placebo
vilobelimab infusion
Placebo Infusion
Efficacy of treatment with vilobelimab compared to placebo
Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
Time frame: Week 1 to Week 26
Efficacy of treatment with vilobelimab compared to placebo
Proportion of patients achieving disease remission up to and including EOT visit; where disease remission is assessed by the investigator as complete re-epithelization (defined as wound covered by epithelial skin layer or scar) of all PG ulcers, without drainage or dressing requirements
Time frame: 2 weeks between study visits
Pain reduction
Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline
Time frame: Week 10 through study completion
Ran from Nov 2023 to primary completion in Jul 2025, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vilobelimab
InflaRx GmbH