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Completed

NCT Number: NCT03971643

Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

InflaRx Site #01, Richmond Hill, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vilobelimab

Drug

IV infusions of vilobelimab diluted in sodium chloride.

Other names: IFX-1, CaCP29

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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

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

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

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

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

    Efficacy endpoint: Percentage change in wound area [percent change] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16.

  4. Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment

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

    Efficacy endpoint: Percentage change in wound volume [percent change] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16.

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

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

    Efficacy endpoint: Rate of change per day in area of target ulcer [mm²/day] between Visits V1 and V16 (photographic assessment)

  6. Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16

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

    Efficacy endpoint: Number of patients with a decrease in area of target ulcer of ≥ 50% by photographic assessment at Visit V16 (EOT) compared to Baseline

  7. Number of Patients With 100% Decrease in Area of Target Ulcer at V16

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

    Efficacy endpoint: Number of patients with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to Baseline (remission) (photographic assessment)

  8. Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16

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

    Efficacy endpoint: Degree of erythema of the target ulcer at Visit V4, V6, V10 and V16 (EOT) (investigator assessment)

  9. Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16

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

    Efficacy endpoint: Border elevation of the target ulcer at visits V4, V6, V10 and V16 (EOT) (investigator assessment)

  10. Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16

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

    Efficacy endpoint: Percentage change from Baseline in pain assessed by Numeric Rating Scale (NRS) [percent change] at visits V4, V6, V10 and V16 (EOT) Mean (SD)

    The NRS is an 11-point scale (from 0 represent no pain to 10 representing the worst pain the subject can imagine).

  11. Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16

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

    Efficacy endpoint: Percentage change from Baseline in Dermatology Life Quality Index (DLQI) [percent change] at visits V4, V6, V10, and V16 (EOT)

    The DLQI comprises 10 questions with single scores 0 (No effect on patient's life) to 3 (large effect on patient's life). The DLQI total score is calculated by summing up the score of each question resulting in a minimum of 0 (best) and a maximum of 30 (worst).

Sponsors and collaborators

Lead sponsor

InflaRx GmbH

Industry

Collaborators

  • Innovaderm Research Inc.

Registry information

Official study title

Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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