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

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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:	August 2023
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:	August 18, 2023 October 23, 2023
Last Update Posted:	August 21 October 24, 2023 [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:	Camilla Chong, MD Telephone: +49 89 414 189 78 00 Email: camilla.chong@inflarx.de
Central Contact Backup:	Alex GO Loayza, Prof, MD Telephone: +49 89 414 189 78 00
Locations:	United States, Florida
	Inflarx Site 102 [Recruiting] Florida City, Florida, United States, 15416 33613
	InflaRx Site 0113 [Recruiting] Hialeah, Florida, United States, 33016
	United States, Georgia
	InflaRx Site 0106 [Recruiting] Sandy Springs, Georgia, United States, 30328
	United States, North Carolina
	InflaRx Site 0105 [Recruiting] Chapel Hill, North Carolina, United States, 27516
	United States, Ohio
	InflaRx Site 0103, Columbus, [Recruiting] Columbus, Ohio, United States, 432115

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: