ClinicalTrials.gg
CompletedNCT03971643Updated Sep 14, 2023Results posted

Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

A Phase 2 interventional study of vilobelimab in Pyoderma Gangrenosum, sponsored by InflaRx GmbH. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pyoderma Gangrenosum

Browse trials for

03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

This study's enrollment of 19 is above the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (>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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    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.

    Drug: vilobelimab

  • Experimental
    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.

    Drug: vilobelimab

  • Experimental
    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.

    Drug: vilobelimab

Interventions

  • IV infusions of vilobelimab diluted in sodium chloride.

    Also known as: IFX-1, CaCP29

06

What researchers measure

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.

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

Secondary outcomes

  1. 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)

  2. 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

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

    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.

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

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

    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.

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

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

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

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

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

    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

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

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

    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)

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

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

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

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

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

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

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

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

    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).

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

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

    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).

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

07

Results

Posted Sep 14, 2023

Participant flow

Participant flow — Overall Study
MilestoneVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Started667
Completed until day 99 (evaluable)647
Completed136
Not completed531

Outcome measures

PrimaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs)
ParticipantsVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Treatment-emergent adverse events (TEAEs)645
Related TEAEs022
Serious TEAEs112
Adverse events of special interest (AESIs) as identified by investigator011
Adverse events of special interest (AESIs) as identified by sponsor212
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment)
ParticipantsVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V4200
V6113
V10315
V16015
SecondaryTime 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
Reported as:
Median · days
Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days]
daysVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days]NA (62 to NA)NA (NA to NA)126 (77 to 197)
SecondaryPercentage Change in Wound Healing (Wound Area) by Photographic Assessment

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.

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Mean · percent change
Percentage Change in Wound Healing (Wound Area) by Photographic Assessment
percent changeVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V1-V4-13.612 ± 41.786216.099 ± 15.0992-12.620 ± 31.9371
V1-V6-4.130 ± 74.1725-8.413 ± 47.5261-34.153 ± 53.3455
V1-V16234.068-57.538 ± 60.0506-90.918 ± 16.2280
V6-V10-22.803 ± 52.8937-16.198 ± 58.8229-63.059 ± 50.1507
V10-V1661.4518.644 ± 5.2038-51.141 ± 69.4133
SecondaryPercentage Change in Wound Healing (Wound Volume) by Photographic Assessment

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.

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Mean · percent change
Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment
percent changeVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V1-V4-19.733 ± 53.428274.918-36.328 ± 32.3445
V1-V6-17.300 ± 90.9283—-58.959 ± 46.7969
V1-V16786.937—-92.639 ± 15.6580
V6-V10-38.033 ± 82.8031-100.000-82.525 ± 30.2680
V10-V16150.857—4.167 ± 177.7658
SecondaryRate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16

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

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Mean · mm²/day
Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16
mm²/dayVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V1615.14-12.04 ± 9.638-9.58 ± 10.751
SecondaryNumber of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16

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

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Count of participants · Participants
Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16
ParticipantsVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16016
SecondaryNumber of Patients With 100% Decrease in Area of Target Ulcer at V16

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)

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Count of participants · Participants
Number of Patients With 100% Decrease in Area of Target Ulcer at V16
ParticipantsVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Number of Patients With 100% Decrease in Area of Target Ulcer at V16012
SecondaryDegree of Erythema of the Target Ulcer at V4, V6, V10 and V16

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

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Count of participants · Participants
Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16
ParticipantsVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V4 — None (0)000
V4 — Slight (1)000
V4 — Moderate (2)221
V4 — Severe (3)334
V4 — Very severe (4)112
V6 — None (0)100
V6 — Slight (1)001
V6 — Moderate (2)222
V6 — Severe (3)223
V6 — Very severe (4)101
V10 — None (0)100
V10 — Slight (1)013
V10 — Moderate (2)311
V10 — Severe (3)222
V10 — Very severe (4)000
V16 — None (0)010
V16 — Slight (1)015
V16 — Moderate (2)001
V16 — Severe (3)110
V16 — Very severe (4)000
SecondaryBorder Elevation of the Target Ulcer at Visits V4, V6, V10 and V16

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

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Count of participants · Participants
Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16
ParticipantsVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V4 — None (0)000
V4 — Slight (1)200
V4 — Moderate (2)154
V4 — Severe (3)303
V4 — Very severe (4)010
V6 — None (0)201
V6 — Slight (1)101
V6 — Moderate (2)234
V6 — Severe (3)111
V6 — Very severe (4)000
V10 — None (0)100
V10 — Slight (1)216
V10 — Moderate (2)330
V10 — Severe (3)000
V10 — Very severe (4)000
V16 — None (0)011
V16 — Slight (1)014
V16 — Moderate (2)111
V16 — Severe (3)000
V16 — Very severe (4)000
SecondaryPercentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16

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).

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Mean · percent change
Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16
percent changeVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V1-V4-41.6 ± 31.2910.6 ± 19.88-41.4 ± 33.77
V1-V6-43.3 ± 16.431.7 ± 22.19-45.0 ± 45.23
V1-V10-64.3 ± 32.5532.5 ± 89.87-72.2 ± 32.07
V1-V16-22.25.6 ± 141.75-51.6 ± 33.89
SecondaryPercentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16

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).

Time frame:
From treatment start until V16 (Day 189)
Reported as:
Mean · percent change
Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16
percent changeVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
V1-V4-29.9 ± 22.75-3.8 ± 51.05-33.1 ± 28.61
V1-V6-31.4 ± 20.29-33.2 ± 29.68-24.7 ± 34.30
V1-V10-50.0 ± 28.01-33.9 ± 31.26-43.1 ± 28.17
V1-V164.5-2 ± 56.07-50.8 ± 45.10

Adverse events

Collected over From treatment start until end of study (including observational visits), an average of 249 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vilobelimab 800 mg Q2W0/6 (0%)1/6 (16.7%)6/6 (100%)
Vilobelimab 1600 mg Q2W0/6 (0%)1/6 (16.7%)3/6 (50%)
Vilobelimab 2400 mg Q2W0/7 (0%)2/7 (28.6%)5/7 (71.4%)
Most frequent serious events
Most frequent serious events
EventVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
EndocarditisInfections and infestations1/60/60/7
Intervertebral discitisInfections and infestations1/60/60/7
PneumoniaInfections and infestations1/60/60/7
SepsisInfections and infestations1/60/60/7
RashSkin and subcutaneous tissue disorders0/61/60/7
ErysipelasInfections and infestations0/60/61/7
Superinfection bacterialInfections and infestations0/60/61/7
Pyoderma gangrenosumSkin and subcutaneous tissue disorders0/60/61/7
Most frequent other events
Showing 10 of 38
Most frequent other events
EventVilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2W
Wound infectionInfections and infestations2/61/60/7
Wound infection pseudomonasInfections and infestations2/60/60/7
Dermatitis contactSkin and subcutaneous tissue disorders2/60/60/7
Traumatic haematomaInjury, poisoning and procedural complications2/60/60/7
Pyoderma gangrenosumSkin and subcutaneous tissue disorders0/60/62/7
CellulitisInfections and infestations1/60/60/7
GingivitisInfections and infestations1/60/60/7
ImpetigoInfections and infestations1/60/60/7
NasopharyngitisInfections and infestations1/60/60/7
Urinary tract infectionInfections and infestations1/60/60/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)Vilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2WTotal
Mean59.5 ± 11.4160.5 ± 12.3643.0 ± 15.0053.7 ± 14.99
Sex: Female, Male
Sex: Female, Male(Participants)Vilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2WTotal
Female43310
Male2349
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Vilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2WTotal
Hispanic or Latino0011
Not Hispanic or Latino66618
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Vilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2WTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0202
White64717
More than one race0000
Unknown or Not Reported0000
Baseline Disease Characteristic: Duration of pyoderma gangrenosum
Baseline Disease Characteristic: Duration of pyoderma gangrenosum(years)Vilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2WTotal
Mean1.7 ± 1.865.7 ± 9.543.4 ± 6.053.6 ± 6.41
Baseline Disease Characteristic: Wound area at baseline
Baseline Disease Characteristic: Wound area at baseline(area [mm²])Vilobelimab 800 mg Q2WVilobelimab 1600 mg Q2WVilobelimab 2400 mg Q2WTotal
Mean1692.374 ± 1391.43077898.952 ± 5844.59411827.553 ± 1901.28303573.500 ± 4320.3723
08

Study locations

10 sites
  • InflaRx Site #07
    Sacramento, California 95816, United States
  • InflaRx Site #08
    Miami, Florida 33125, United States
  • InflaRx Site #03
    Tampa, Florida 33613, United States
  • InflaRx Site #10
    Saint Louis, Missouri 63110, United States
  • InflaRx Site #05
    Columbus, Ohio 43210, United States
  • InflaRx Site #12
    Hershey, Pennsylvania 17033, United States
  • InflaRx Site #09
    Pittsburgh, Pennsylvania 15213, United States
  • InflaRx Site #01
    Richmond Hill, Ontario, Canada
  • InflaRx Site #21
    Rzeszów, 35-055, Poland
  • InflaRx Site #20
    Wrocław, 50-566, Poland
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03971643
Lead sponsor
InflaRx GmbH
Collaborators
Innovaderm Research Inc.
Responsible party
Sponsor
First posted
Jun 3, 2019
Start date
May 16, 2019
Primary completion
Jan 3, 2022
Completion
Jan 3, 2022
Results posted
Sep 14, 2023
Last update
Sep 14, 2023

Study contacts

Prof. Niels C. Riedemann, M.D., Ph.D.
study director · InflaRx GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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