History of Changes for Study: NCT05964413

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

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Study Record Versions

Version	Submitted Date	Changes
1	July 24, 2023	None (earliest Version on record)
2	July 28, 2023	Study Status
3	August 18, 2023	Recruitment Status, Arms and Interventions, Study Status, Outcome Measures, Contacts/Locations, Eligibility, Oversight and Study Identification
4	October 23, 2023	Contacts/Locations and Study Status
5	November 1, 2023	Study Status and Contacts/Locations
6	November 11, 2023	Contacts/Locations and Study Status
7	January 9, 2024	Contacts/Locations and Study Status
8	January 17, 2024	Contacts/Locations and Study Status
9	March 1, 2024	Study Status and Contacts/Locations
10	April 27, 2024	Contacts/Locations and Study Status
11	May 16, 2024	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	IFX-1-P3.4
Brief Title:	Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
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
Secondary IDs:

Study Status


Record Verification:	April 2024
Overall Status:	Recruiting
Study Start:	August 15, 2023
Primary Completion:	February 13, 2026 [Anticipated]
Study Completion:	May 15, 2026 [Anticipated]

First Submitted:	June 29, 2023
First Submitted that Met QC Criteria:	July 24, 2023
First Posted:	July 27, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	April 27, 2024
Last Update Posted:	April 30, 2024 [Actual]

Sponsor/Collaborators


Sponsor:	InflaRx GmbH
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description


Brief 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
Detailed Description:

Conditions


Conditions:	Pyoderma Gangrenosum
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	90 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: vilobelimab Patients will be treated with vilobelimab IV, Q2W for 26 weeks	Drug: vilobelimab vilobelimab infusion
Placebo Comparator: Placebo Patients will receive placebo IV in the same schedule as patients in Arm 1	Drug: Placebo Placebo Infusion

Outcome Measures


Primary Outcome Measures:
1.	Efficacy of treatment with vilobelimab compared to placebo [ Time Frame: Week 1 to Week 26 ] Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
Secondary Outcome Measures:
1.	Efficacy of treatment with vilobelimab compared to placebo [ Time Frame: 2 weeks between study visits ] 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
2.	Pain reduction [ Time Frame: Week 10 through study completion ] Proportion of patients achieving a pain reduction related to the target ulcer of at least 3 points compared to baseline

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Main Inclusion Criteria: 18 years or older at the time of signing the informed consent. 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. 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: Patients with target ulcers exceeding 80 cm 2 . Patients with target ulcer in transplanted skin. 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). Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP). Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP). 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). Patients received any systemic medical treatment for PG within 4 weeks prior to baseline 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. 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).

Contacts/Locations


Central Contact Person:	Dorothee Neukirchen, Dr. Telephone: +49 89 4141897800 Email: clinicaltrials@inflarx.de
Central Contact Backup:	Alex GO Loayza, Prof, MD Telephone: +49 89 414 189 78 00
Locations:	United States, Florida
	Aby´s New Generation Research, Inc [Recruiting] Hialeah, Florida, United States, 33016
	Dermatology/University of Miami Hospital [Recruiting] Miami, Florida, United States, 33146
	University of Central Florida College of Medicine [Recruiting] Orlando, Florida, United States, 32827
	ForCare Clinical Research [Recruiting] Tampa, Florida, United States, 33613
	United States, Georgia
	Advanced Medical Research, PC [Recruiting] Sandy Springs, Georgia, United States, 30328
	United States, Massachusetts
	Brigham and Women's Hospital [Recruiting] Boston, Massachusetts, United States, 02115
	Brigham and Women´s Hospital [Recruiting] Boston, Massachusetts, United States, 02115
	United States, North Carolina
	University of North Carolina at Chapel Hill Department of Dermatology [Recruiting] Chapel Hill, North Carolina, United States, 27516
	United States, Ohio
	Ohio State University [Recruiting] Columbus, Ohio, United States, 432115
	Apex Clinical Research Center [Recruiting] Mayfield Heights, Ohio, United States, 44124
	Apex Clinical Research Center [Recruiting] Ohio City, Ohio, United States, 44124
	United States, Oregon
	Oregon Health and Science University [Recruiting] Portland, Oregon, United States, 97239
	United States, Pennsylvania
	University of Pennsylvania [Recruiting] Philadelphia, Pennsylvania, United States, 19194
	United States, Texas
	The University of Texas Health Science Center at Houston [Recruiting] Bellaire, Texas, United States, 77401
	Australia
	Veracity Clinical Research Center [Recruiting] Brisbane, Australia, 4102
	Veracity Clinical Research Pty Ltd (ACN 163 889 361) as trustee for the MLS Trust (ABN 49 688 437 341) [Recruiting] Brisbane, Australia
	The Alfred Hospital, Melbourne [Recruiting] Melbourne, Australia
	Australia, New South Wales
	Premier Specialists [Recruiting] Kogarah, New South Wales, Australia, 2217
	Australia, NewSouth Wales
	Premier Specialists [Recruiting] Kogarah, NewSouth Wales, Australia
	Australia, Victoria
	The Alfred Hospital, Melbourne [Recruiting] Melbourne, Victoria, Australia, 3004
	France
	Hospital Edouard Herriot [Recruiting] Lyon, France, 69003
	Hopital Edouard Herriot [Recruiting] Lyon, France
	CHU de Nantes - Clinique dermatologique [Recruiting] Nantes, France
	Saint Louis Hospital [Recruiting] Paris, France, 75010
	Saint Louis Hospital [Recruiting] Paris, France
	CHU Toulouse - Hôpital Larrey [Recruiting] Toulouse, France
	France, Occitanie
	CHU Toulouse Hospital Larrey [Recruiting] Toulouse, Occitanie, France, 31000
	Germany
	Charite Universitätsmedizin Berlin [Recruiting] Berlin, Germany, 10117
	Charité - Universitätsmedizin Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany [Recruiting] Berlin, Germany
	Berge Hautklinik Uniklinikum Erlangen [Recruiting] Erlangen, Germany
	Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie [Recruiting] Frankfurt, Germany
	University Hospital Leipzig AöR [Recruiting] Leipzig, Germany
	Germany, Baden Würrtemberg
	Universitätshautklinik Tübingen [Recruiting] Tübingen, Baden Würrtemberg, Germany, 72076
	Germany, Bavaria
	Berge Hautklinik [Recruiting] Erlangen, Bavaria, Germany, 91054
	Universitätsklinikum Heidelberg [Recruiting] Heidelberg, Bavaria, Germany, 69120
	Klinik und Poliklinik für Dermatologie und Allergologie [Recruiting] München, Bavaria, Germany, 80337
	University Hospital Würzburg, Department of Dermatology [Recruiting] Würzburg, Bavaria, Germany, 97080
	Germany, Hessen
	Universitätsklinikum Frankfurt, Klinik für Dermatologie [Recruiting] Frankfurt, Hessen, Germany, 60590
	Germany, Nordrhein-Westfalen
	University of Essen, Germany [Recruiting] Essen, Nordrhein-Westfalen, Germany
	Germany, Nordrhein-Westfalia
	Catholic Clinic Bochum, Department of Dermatology [Recruiting] Bochum, Nordrhein-Westfalia, Germany, 44791
	Hungary
	Department of Dermatology, Venerology and Oncodermatology, University of Pécs [Recruiting] Pécs, Hungary
	Department of Dermatology and Allergology, University of Szeged [Recruiting] Szeged, Hungary
	Hungary, Baranya
	Department of Dermatology and Venerology and Oncodermatology, University of Pecs [Recruiting] Pécs, Baranya, Hungary, 7632
	Hungary, Csongrad-Csanad
	Department of Dermatology and Allergology, University of Szeged [Recruiting] Szeged, Csongrad-Csanad, Hungary, 6720
	Hungary, Hadju-Bihar
	Department of Dermatology, University of Debrecen [Recruiting] Debrecen, Hadju-Bihar, Hungary, 4032
	Italy
	Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico SC Dermatologia [Recruiting] Milan, Italy, 20122
	University of Pisa, Santa Chiara Hospital [Recruiting] Pisa, Italy, 56124
	PIsa University of Pisa Santa Chiara Hospital [Recruiting] Pisa, Italy
	AOU Città della salute e della scienza [Recruiting] Turin, Italy
	Poland
	Państwowy Instytut Medyczny CSK MSWiA [Recruiting] Warsaw, Poland
	City Clinic Przychodnia Lekarsko-Psychologiczna ul. Sliczna 13, Wroclaw, Poland [Recruiting] Wrocław, Poland
	Wojewódzki Specjalistyczny Szpital im. Dr Wł. Biegańskiego w Łodzi; Klinika Dermatologii, Dermatologii Dziecięcej i Onkologicznej Uniwersytetu Medycznego [Recruiting] Łódź, Poland
	Poland, Lower Silesia
	City Clinic Lekarsko Psychologiczna ul. Sliczna 13, Wroclaw [Recruiting] Wrocław, Lower Silesia, Poland, 50-566
	Poland, Mazowsze
	Paistowny Instytut Mediczny CSK [Recruiting] Warsaw, Mazowsze, Poland, 02-507
	Poland, Warminsko
	Clinic of Dermatology, Transmitted Diseases and Clinical Immunology [Recruiting] Olsztyn, Warminsko, Poland, 10229
	Spain
	Complejo Asistencial Universitario de Salamanca [Recruiting] Salamanca, Spain, 37007
	Switzerland
	University Hospital Basel [Recruiting] Basel, Switzerland, 4055
	University Hospital Basel Department of Dermatology at Universitäre Altersmedizin FELIX PLATTER [Recruiting] Basel, Switzerland

IPDSharing


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References


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