Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

InflaRx GmbH19 enrolled

Overview

The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.

Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that vilobelimab might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pyoderma Gangrenosum

Interventions

vilobelimabDRUG

IV infusions of vilobelimab diluted in sodium chloride.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator In addition, the subject must fulfill at least 3 of the following 6 criteria at screening: History of * Pathergy (ulcer occurring at the sites of trauma) * Personal history of inflammatory bowel disease or inflammatory arthritis * History of papule, pustule or vesicle that rapidly ulcerated Clinical examination (or photographic evidence) of * Peripheral erythema, undermining border, and tenderness at site of ulceration * Multiple ulcerations (at least 1 occurring on the lower leg) * Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening Exclusion Criteria: * Pyoderma gangrenosum target ulcer for more than 3 years before screening * Surgical wound debridement within the previous 2 weeks before screening * Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening * Any drug treatment for pyoderma gangrenosum including corticosteroids (\>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening

Locations (10)

InflaRx Site #07

Sacramento, California, United States

InflaRx Site #08

Miami, Florida, United States

InflaRx Site #03

Tampa, Florida, United States

InflaRx Site #10

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs)

Number of patients with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest (AESIs) TEAEs are defined as adverse events that start at or after the first administration of study drug. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study drug. AESIs are defined as infusion-related reactions, including acute and delayed hypersensitivity and anaphylactic reactions during or after infusion; Meningitis; Meningococcal septicaemia; Invasive infection. As adverse events will be reported in details in the safety section, no separate reporting on System Organ Class (SOC) or Preferred Term (PT) level etc. is done here.

Time frame: From treatment start until end of study (including observational visits), an average of 249 days

Secondary Outcomes

Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment)

Efficacy endpoint: Proportion of patients with a clinical response, defined as Physician's Global Assessment (PGA) score ≤3 of target ulcer at Visit V4, V6, V10 and V16 (End of Treatment \[EOT\]) (SAF). PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse

Time frame: From treatment start until V16 (Day 189)

Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days]

Efficacy endpoint: Kaplan-Meier analysis of time to first clinical remission (complete closure of target ulcer) defined as PGA score of ≤ 1, PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse

Time frame: From treatment start until end of study (including observational visits), an average of 249 days

Percentage Change in Wound Healing (Wound Area) by Photographic Assessment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.