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Pyoderma GangrenosumPhase 3NCT05964413

Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

A Phase 3 study testing vilobelimab in people with Pyoderma Gangrenosum, run by InflaRx GmbH at 50 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pyoderma Gangrenosum
What is being tested?
vilobelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
50 sitesin 10 countries
Study dates
1 Nov 2023to 11 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Trial locations and contacts

50 sites in 10 countries.

50 sites in 10 countries

Germany13 sites

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

    Berlin

  • Catholic Clinic Bochum, Department of Dermatology

    Bochum, Nordrhein-Westfalia, 44791

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

    Düsseldorf

  • Berge Hautklinik

    Erlangen, Bavaria, 91054

  • University of Essen, Germany

    Essen, North Rhine-Westphalia

  • Universitätsklinikum Frankfurt, Klinik für Dermatologie

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinik für Dermatologie und Venerologie der MLU Halle

    Halle

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

    Hamburg

  • Universitätsklinikum Heidelberg

    Heidelberg, Bavaria, 69120

  • University Hospital Leipzig AöR

    Leipzig

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München, Bavaria, 80337

  • Universitätshautklinik Tübingen

    Tübingen, Baden Würrtemberg, 72076

  • University Hospital Würzburg, Department of Dermatology

    Würzburg, Bavaria, 97080

Other trials in Germany

United States12 sites

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

  • Brigham and Women´s Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina at Chapel Hill Department of Dermatology

    Chapel Hill, North Carolina, 27516

  • Ohio State University Wexner Medical Cente OSU Dermatology West

    Columbus, Ohio, 43215

  • Aby´s New Generation Research, Inc

    Hialeah, Florida, 33016

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124

  • Dermatology/University of Miami Hospital

    Miami, Florida, 33146

  • University of Central Florida College of Medicine

    Orlando, Florida, 32827

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19194

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Advanced Medical Research, PC

    Sandy Springs, Georgia, 30328

  • ForCare Clinical Research

    Tampa, Florida, 33613

Other trials in United States

Poland5 sites

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

    Lodz

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

    Lublin

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

    Olsztyn

  • Państwowy Instytut Medyczny CSK MSWiA

    Warsaw

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

    Wroclaw

Other trials in Poland

Australia4 sites

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

    Brisbane

  • Premier Specialists

    Kogarah, NewSouth Wales

  • The Alfred Hospital, Melbourne

    Melbourne, Victoria, 3004

  • Liverpool Hospital

    Sydney

Other trials in Australia

France4 sites

  • Hospital Edouard Herriot

    Lyon, 69003

  • CHU de Nantes - Clinique dermatologique

    Nantes, 44093

  • Saint Louis Hospital

    Paris, 75010

  • CHU Toulouse Hospital Larrey

    Toulouse, Occitanie, 31000

Other trials in France

Italy4 sites

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

    Bologna

  • Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia

    Milan, 20122

  • Ospedale Santa Chiara

    Pisa, 56126

  • AOU Città della salute e della scienza

    Turin

Other trials in Italy

Hungary3 sites

  • Department of Dermatology, University of Debrecen

    Debrecen, Hadju-Bihar, 4032

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

    Pécs

  • Department of Dermatology and Allergology, University of Szeged

    Szeged, Csongrad-Csanad, 6720

Other trials in Hungary

Belgium2 sites

  • Hôpitaux Universitaires de Bruxelles

    Anderlecht

  • Cliniques Universitaires Saint-Luc

    Brussels

Other trials in Belgium

Spain2 sites

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Complejo Asistencial Universitario de Salamanca

    Salamanca

Other trials in Spain

Switzerland1 site

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

    Basel

Other trials in Switzerland

About this study

Official title: 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

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

Being tested
vilobelimab, Placebo
Medical subject headings
Pyoderma Gangrenosum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vilobelimabDrug

    vilobelimab infusion

  • PlaceboDrug

    Placebo Infusion

Study groups in NCT05964413
Study groupRoleWhat they receive
vilobelimabExperimentalPatients will be treated with vilobelimab IV, Q2W for 26 weeks
Receives: Drug: vilobelimab
PlaceboPlacebo comparatorPatients will receive placebo IV in the same schedule as patients in Arm 1
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of treatment with vilobelimab compared to placebo

    Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer

    Measured: Week 1 to Week 26

Secondary outcomes (2)

  1. 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

    Measured: 2 weeks between study visits

  2. Pain reduction

    Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline

    Measured: Week 10 through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start1 Nov 2023
  3. Primary completion11 Jul 2025
  4. Study completion11 Jul 2025

Why it stopped: Study stopped for futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964413
Sponsor's protocol ID
IFX-1-P3.4
Status last verified
Nov 2025
First submitted
29 Jun 2023
Last updated
4 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vilobelimab in people with Pyoderma Gangrenosum, run by InflaRx GmbH at 50 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany, United States, Poland, Australia, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped for futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of treatment with vilobelimab compared to placebo (time frame: Week 1 to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05964413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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