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

Phase 3

Recruiting

• Conditions: Pyoderma Gangrenosum
• Interventions: Drug: vilobelimab; Drug: Placebo

• Registration Number: NCT05964413
• Lead Sponsor: InflaRx GmbH

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

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-27
• Study Start: 2023-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-02-13
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vilobelimab	vilobelimab	Patients will be treated with vilobelimab IV, Q2W for 26 weeks
Placebo	Placebo	Patients will receive placebo IV in the same schedule as patients in Arm 1

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment with vilobelimab compared to placebo	Week 1 to Week 26	Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment with vilobelimab compared to placebo	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
Pain reduction	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

Trial Locations

Locations (50)

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Aby´s New Generation Research, Inc; 🇺🇸 Hialeah, Florida, United States

Dermatology/University of Miami Hospital; 🇺🇸 Miami, Florida, United States

University of Central Florida College of Medicine; 🇺🇸 Orlando, Florida, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Advanced Medical Research, PC; 🇺🇸 Sandy Springs, Georgia, United States

Brigham and Women´s Hospital; 🇺🇸 Boston, Massachusetts, United States

University of North Carolina at Chapel Hill Department of Dermatology; 🇺🇸 Chapel Hill, North Carolina, United States

Ohio State University Wexner Medical Cente OSU Dermatology West; 🇺🇸 Columbus, Ohio, United States

Apex Clinical Research Center; 🇺🇸 Mayfield Heights, Ohio, United States

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