Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

NCT03971643 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IFX-1-P2.7
• Study Type: interventional
• Target: 19
• Locations: 3 countries
• Sites: 10

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.

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (11)

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

  From treatment start until V16 (Day 189)

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

  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

  From treatment start until V16 (Day 189)

• Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment

  From treatment start until V16 (Day 189)

• Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16

  From treatment start until V16 (Day 189)

Study Arms (3)

vilobelimab 800 mg Q2W

EXPERIMENTAL

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.

Drug: vilobelimab

vilobelimab 1600 mg Q2W

EXPERIMENTAL

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.

Drug: vilobelimab

vilobelimab 2400 mg Q2W

EXPERIMENTAL

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.

Drug: vilobelimab

Interventions

vilobelimab DRUG

IV infusions of vilobelimab diluted in sodium chloride.

Also known as: IFX-1, CaCP29

vilobelimab 1600 mg Q2W; vilobelimab 2400 mg Q2W; vilobelimab 800 mg Q2W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InflaRx GmbH: lead
• Innovaderm Research Inc.: collaborator

Study Sites (10)

InflaRx Site #07

Sacramento, California, 95816, United States

Location

InflaRx Site #08

Miami, Florida, 33125, United States

Location

InflaRx Site #03

Tampa, Florida, 33613, United States

Location

InflaRx Site #10

St Louis, Missouri, 63110, United States

Location

InflaRx Site #05

Columbus, Ohio, 43210, United States

Location

InflaRx Site #12

Hershey, Pennsylvania, 17033, United States

Location

InflaRx Site #09

Pittsburgh, Pennsylvania, 15213, United States

Location

InflaRx Site #01

Richmond Hill, Ontario, Canada

Location

InflaRx Site #21

Rzeszów, 35-055, Poland

Location

InflaRx Site #20

Wroclaw, 50-566, Poland

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

vilobelimab

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Results Point of Contact

• Title: Prof. Dr. Niels C. Riedemann
• Organization: InflaRx

niels.riedemann@inflarx.de

+49-(0) 3641-508 180

Study Officials

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

  InflaRx GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: IV infusions of vilobelimab diluted in sodium chloride

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: May 16, 2019
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (1); PL (2)