Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

InflaRx

Status and phase: Completed; Phase 2

Conditions: Pyoderma Gangrenosum

Treatments: Drug: vilobelimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03971643

IFX-1-P2.7

Details and patient eligibility

About

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

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

vilobelimab 800 mg Q2W

Experimental group

Description:

Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W.

Treatment:

Drug: vilobelimab

vilobelimab 1600 mg Q2W

Experimental group

Description:

Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W.

Treatment:

Drug: vilobelimab

vilobelimab 2400 mg Q2W

Experimental group

Description:

Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 3 (N=7) received vilobelimab 2400 mg every Q2W.

Treatment:

Drug: vilobelimab