Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

NCT ID: NCT03971643

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2022-01-03

Brief Summary

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

Detailed 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.

Conditions

Pyoderma Gangrenosum

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vilobelimab 800 mg Q2W

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.

Group Type: EXPERIMENTAL

vilobelimab

Intervention Type: DRUG

IV infusions of vilobelimab diluted in sodium chloride.

vilobelimab 1600 mg Q2W

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.

Group Type: EXPERIMENTAL

vilobelimab

Intervention Type: DRUG

IV infusions of vilobelimab diluted in sodium chloride.

vilobelimab 2400 mg Q2W

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.

Group Type: EXPERIMENTAL

vilobelimab

Intervention Type: DRUG

IV infusions of vilobelimab diluted in sodium chloride.

Interventions

vilobelimab

IV infusions of vilobelimab diluted in sodium chloride.

Intervention Type: DRUG

Other Intervention Names

IFX-1; CaCP29

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovaderm Research Inc.

OTHER

Sponsor Role: collaborator

InflaRx GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Niels C. Riedemann, M.D., Ph.D.

Role: STUDY_DIRECTOR

InflaRx GmbH

Locations

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

InflaRx Site #05

Columbus, Ohio, United States

InflaRx Site #12

Hershey, Pennsylvania, United States

InflaRx Site #09

Pittsburgh, Pennsylvania, United States

InflaRx Site #01

Richmond Hill, Ontario, Canada

InflaRx Site #21

Rzeszów, , Poland

InflaRx Site #20

Wroclaw, , Poland

Countries

United States; Canada; Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IFX-1-P2.7

Identifier Type: -

Identifier Source: org_study_id