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Promising drug trial for painful skin ulcers halted early

NCT ID NCT05964413

Disease control Sponsor: InflaRx GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called vilobelimab for people with pyoderma gangrenosum, a rare condition causing painful skin ulcers. The trial aimed to see if the drug could completely close the ulcers compared to a placebo. It included 54 adults and was stopped early, so the results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

54 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

classic pyoderma gangrenosum pyoderma gangrenosum

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pyoderma gangrenosum

Contacts and locations

Locations

  • AOU Città della salute e della scienza

    Turin, Italy

  • Aby´s New Generation Research, Inc

    Hialeah, Florida, 33016, United States

  • Advanced Medical Research, PC

    Sandy Springs, Georgia, 30328, United States

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124, United States

  • Berge Hautklinik

    Erlangen, Bavaria, 91054, Germany

  • Brigham and Women´s Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Toulouse Hospital Larrey

    Toulouse, Occitanie, 31000, France

  • CHU de Nantes - Clinique dermatologique

    Nantes, 44093, France

  • Catholic Clinic Bochum, Department of Dermatology

    Bochum, Nordrhein-Westfalia, 44791, Germany

  • Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany

    Berlin, Germany

  • City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland

    Wroclaw, Poland

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, Spain

  • Department and Clinics of Dermatology, Venereology and Paediatric Dermatology, Medical University of Lublin,

    Lublin, Poland

  • Department of Dermatology and Allergology, University of Szeged

    Szeged, Csongrad-Csanad, 6720, Hungary

  • Department of Dermatology, University of Debrecen

    Debrecen, Hadju-Bihar, 4032, Hungary

  • Department of Dermatology, Venerology and Oncodermatology, University of Pécs

    Pécs, Hungary

  • Dermatology/University of Miami Hospital

    Miami, Florida, 33146, United States

  • Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia

    Milan, 20122, Italy

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • Hospital Edouard Herriot

    Lyon, 69003, France

  • Hospital Ramón y Cajal

    Madrid, 28034, Spain

  • Hôpitaux Universitaires de Bruxelles

    Anderlecht, Belgium

  • IRCCS Policlinico di Sant'Orsola Alma Mater Studiorum - University of Bologna

    Bologna, Italy

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München, Bavaria, 80337, Germany

  • Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klininczej, Miejski Szpital Zespolony w Olsztynie Clinic of Dermatology,

    Olsztyn, Poland

  • Liverpool Hospital

    Sydney, Australia

  • Ohio State University Wexner Medical Cente OSU Dermatology West

    Columbus, Ohio, 43215, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale Santa Chiara

    Pisa, 56126, Italy

  • Państwowy Instytut Medyczny CSK MSWiA

    Warsaw, Poland

  • Premier Specialists

    Kogarah, NewSouth Wales, Australia

  • Saint Louis Hospital

    Paris, 75010, France

  • The Alfred Hospital, Melbourne

    Melbourne, Victoria, 3004, Australia

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401, United States

  • University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER

    Basel, Switzerland

  • University Hospital Leipzig AöR

    Leipzig, Germany

  • University Hospital Würzburg, Department of Dermatology

    Würzburg, Bavaria, 97080, Germany

  • University clinic Duesseldorf Department of Dermatology Heinrich-Heine-University Duesseldorf

    Düsseldorf, Germany

  • University of Central Florida College of Medicine

    Orlando, Florida, 32827, United States

  • University of Essen, Germany

    Essen, North Rhine-Westphalia, Germany

  • University of North Carolina at Chapel Hill Department of Dermatology

    Chapel Hill, North Carolina, 27516, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19194, United States

  • Universitätshautklinik Tübingen

    Tübingen, Baden Würrtemberg, 72076, Germany

  • Universitätsklinik für Dermatologie und Venerologie der MLU Halle

    Halle, Germany

  • Universitätsklinikum Frankfurt, Klinik für Dermatologie

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

    Hamburg, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Bavaria, 69120, Germany

  • Veracity Clinical Research Pty Ltd as trustee for the MLS Trust

    Brisbane, Australia

  • Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego

    Lodz, Poland

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