Pyoderma Gangrenosum
Conditions
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.
Interventions
DRUGvilobelimab
IV infusions of vilobelimab diluted in sodium chloride.
Sponsors
Innovaderm Research Inc.
InflaRx GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
IV infusions of vilobelimab diluted in sodium chloride
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | 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. |
| Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | 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. |
| Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | 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) |
| Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | 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 |
| Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | 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 |
| Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | 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) |
| Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | 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) |
| Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | 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). |
| Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | 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). |
| Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | 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) |
Countries
Canada, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vilobelimab 800 mg Q2W 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. | 6 |
| Vilobelimab 1600 mg Q2W 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. | 6 |
| Vilobelimab 2400 mg Q2W Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W). | 7 |
| Total | 19 |
Baseline characteristics
| Characteristic | Vilobelimab 1600 mg Q2W | Vilobelimab 2400 mg Q2W | Vilobelimab 800 mg Q2W | Total |
|---|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 12.36 | 43.0 years STANDARD_DEVIATION 15 | 59.5 years STANDARD_DEVIATION 11.41 | 53.7 years STANDARD_DEVIATION 14.99 |
| Baseline Disease Characteristic: Duration of pyoderma gangrenosum | 5.7 years STANDARD_DEVIATION 9.54 | 3.4 years STANDARD_DEVIATION 6.05 | 1.7 years STANDARD_DEVIATION 1.86 | 3.6 years STANDARD_DEVIATION 6.41 |
| Baseline Disease Characteristic: Wound area at baseline | 7898.952 area [mm²] STANDARD_DEVIATION 5844.5941 | 1827.553 area [mm²] STANDARD_DEVIATION 1901.283 | 1692.374 area [mm²] STANDARD_DEVIATION 1391.4307 | 3573.500 area [mm²] STANDARD_DEVIATION 4320.3723 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 6 / 6 | 3 / 6 | 5 / 7 |
| serious Total, serious adverse events | 1 / 6 | 1 / 6 | 2 / 7 |
Outcome results
Primary
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
Population: Safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vilobelimab 800 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) as identified by investigator | 0 Participants |
| Vilobelimab 800 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Serious TEAEs | 1 Participants |
| Vilobelimab 800 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Treatment-emergent adverse events (TEAEs) | 6 Participants |
| Vilobelimab 800 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Related TEAEs | 0 Participants |
| Vilobelimab 800 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) as identified by sponsor | 2 Participants |
| Vilobelimab 1600 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Serious TEAEs | 1 Participants |
| Vilobelimab 1600 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Treatment-emergent adverse events (TEAEs) | 4 Participants |
| Vilobelimab 1600 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Related TEAEs | 2 Participants |
| Vilobelimab 1600 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) as identified by investigator | 1 Participants |
| Vilobelimab 1600 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) as identified by sponsor | 1 Participants |
| Vilobelimab 2400 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) as identified by sponsor | 2 Participants |
| Vilobelimab 2400 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) as identified by investigator | 1 Participants |
| Vilobelimab 2400 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Treatment-emergent adverse events (TEAEs) | 5 Participants |
| Vilobelimab 2400 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Serious TEAEs | 2 Participants |
| Vilobelimab 2400 mg Q2W | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Related TEAEs | 2 Participants |
Secondary
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)
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Very severe (4) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Moderate (2) | 2 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | None (0) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Severe (3) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Severe (3) | 1 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Severe (3) | 3 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Moderate (2) | 3 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Very severe (4) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Very severe (4) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Slight (1) | 2 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | None (0) | 1 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Moderate (2) | 1 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Very severe (4) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Severe (3) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Slight (1) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | None (0) | 2 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Moderate (2) | 1 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | None (0) | 0 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Slight (1) | 1 Participants |
| Vilobelimab 800 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Slight (1) | 2 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Moderate (2) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | None (0) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Slight (1) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Moderate (2) | 5 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Severe (3) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Very severe (4) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | None (0) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Slight (1) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Moderate (2) | 3 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Severe (3) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Very severe (4) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | None (0) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Slight (1) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Moderate (2) | 3 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Severe (3) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Very severe (4) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | None (0) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Slight (1) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Severe (3) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Slight (1) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Severe (3) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Slight (1) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | None (0) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Severe (3) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | None (0) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | None (0) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Slight (1) | 4 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Severe (3) | 3 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | None (0) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V4 | Moderate (2) | 4 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Slight (1) | 6 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Severe (3) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V16 | Moderate (2) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V10 | Moderate (2) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | V6 | Moderate (2) | 4 Participants |
Secondary
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)
Population: Safety set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Moderate (2) | 2 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Very severe (4) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Moderate (2) | 2 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Very severe (4) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Severe (3) | 2 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Severe (3) | 2 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Very severe (4) | 1 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Moderate (2) | 3 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Severe (3) | 3 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Slight (1) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | None (0) | 1 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Slight (1) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Moderate (2) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Very severe (4) | 1 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | None (0) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Slight (1) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | None (0) | 1 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Severe (3) | 1 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | None (0) | 0 Participants |
| Vilobelimab 800 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Slight (1) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Moderate (2) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | None (0) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Slight (1) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Moderate (2) | 2 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Severe (3) | 3 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Very severe (4) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | None (0) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Slight (1) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Moderate (2) | 2 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Severe (3) | 2 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Very severe (4) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | None (0) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Slight (1) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Moderate (2) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Severe (3) | 2 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Very severe (4) | 0 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | None (0) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Slight (1) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Severe (3) | 1 Participants |
| Vilobelimab 1600 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Slight (1) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Severe (3) | 2 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Slight (1) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Very severe (4) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | None (0) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Severe (3) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | None (0) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Very severe (4) | 2 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | None (0) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Slight (1) | 5 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Severe (3) | 4 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | None (0) | 0 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Very severe (4) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V4 | Moderate (2) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Slight (1) | 3 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Severe (3) | 3 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V16 | Moderate (2) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V10 | Moderate (2) | 1 Participants |
| Vilobelimab 2400 mg Q2W | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | V6 | Moderate (2) | 2 Participants |
Secondary
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)
Population: Safety Set~Only patients with an available wound area measurement at baseline and V16 are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vilobelimab 800 mg Q2W | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | 0 Participants |
| Vilobelimab 1600 mg Q2W | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | 1 Participants |
| Vilobelimab 2400 mg Q2W | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | 2 Participants |
Secondary
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)
Population: Safety Set~Only patients with an available wound area measurement at baseline and V16 are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vilobelimab 800 mg Q2W | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | 0 Participants |
| Vilobelimab 1600 mg Q2W | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | 1 Participants |
| Vilobelimab 2400 mg Q2W | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | 6 Participants |
Secondary
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)
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vilobelimab 800 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V4 | 2 Participants |
| Vilobelimab 800 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V6 | 1 Participants |
| Vilobelimab 800 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V10 | 3 Participants |
| Vilobelimab 800 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V16 | 0 Participants |
| Vilobelimab 1600 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V16 | 1 Participants |
| Vilobelimab 1600 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V4 | 0 Participants |
| Vilobelimab 1600 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V10 | 1 Participants |
| Vilobelimab 1600 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V6 | 1 Participants |
| Vilobelimab 2400 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V16 | 5 Participants |
| Vilobelimab 2400 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V6 | 3 Participants |
| Vilobelimab 2400 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V10 | 5 Participants |
| Vilobelimab 2400 mg Q2W | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | V4 | 0 Participants |
Secondary
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)
Population: Safety set~Only patients with an available DLQI at both relevant visits are included in the respective analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilobelimab 800 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V10 | -50.0 percent change | Standard Deviation 28.01 |
| Vilobelimab 800 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V4 | -29.9 percent change | Standard Deviation 22.75 |
| Vilobelimab 800 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V16 | 4.5 percent change | — |
| Vilobelimab 800 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V6 | -31.4 percent change | Standard Deviation 20.29 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V10 | -33.9 percent change | Standard Deviation 31.26 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V6 | -33.2 percent change | Standard Deviation 29.68 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V4 | -3.8 percent change | Standard Deviation 51.05 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V16 | -2 percent change | Standard Deviation 56.07 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V6 | -24.7 percent change | Standard Deviation 34.3 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V4 | -33.1 percent change | Standard Deviation 28.61 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V16 | -50.8 percent change | Standard Deviation 45.1 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | V1-V10 | -43.1 percent change | Standard Deviation 28.17 |
Secondary
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)
Population: Safety set~Only patients with an available NRS at both relevant visits are included in the respective analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilobelimab 800 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V4 | -41.6 percent change | Standard Deviation 31.29 |
| Vilobelimab 800 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V6 | -43.3 percent change | Standard Deviation 16.43 |
| Vilobelimab 800 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V10 | -64.3 percent change | Standard Deviation 32.55 |
| Vilobelimab 800 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V16 | -22.2 percent change | — |
| Vilobelimab 1600 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V16 | 5.6 percent change | Standard Deviation 141.75 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V4 | 10.6 percent change | Standard Deviation 19.88 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V10 | 32.5 percent change | Standard Deviation 89.87 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V6 | 1.7 percent change | Standard Deviation 22.19 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V16 | -51.6 percent change | Standard Deviation 33.89 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V6 | -45.0 percent change | Standard Deviation 45.23 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V10 | -72.2 percent change | Standard Deviation 32.07 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | V1-V4 | -41.4 percent change | Standard Deviation 33.77 |
Secondary
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)
Population: Safety Set~Only patients with an available wound area measurement at both relevant visits are included in the respective analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V6-V10 | -22.803 percent change | Standard Deviation 52.8937 |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V16 | 234.068 percent change | — |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V4 | -13.612 percent change | Standard Deviation 41.7862 |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V6 | -4.130 percent change | Standard Deviation 74.1725 |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V10-V16 | 61.451 percent change | — |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V16 | -57.538 percent change | Standard Deviation 60.0506 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V4 | 16.099 percent change | Standard Deviation 15.0992 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V6 | -8.413 percent change | Standard Deviation 47.5261 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V6-V10 | -16.198 percent change | Standard Deviation 58.8229 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V10-V16 | 8.644 percent change | Standard Deviation 5.2038 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V10-V16 | -51.141 percent change | Standard Deviation 69.4133 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V6-V10 | -63.059 percent change | Standard Deviation 50.1507 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V4 | -12.620 percent change | Standard Deviation 31.9371 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V16 | -90.918 percent change | Standard Deviation 16.228 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | V1-V6 | -34.153 percent change | Standard Deviation 53.3455 |
Secondary
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)
Population: Safety Set~Only patients with an available wound volume measurement at both relevant visits are included in the respective analysis. Wound volume for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. Additionally, sometimes the pictures allowed to measure the wound area, but not the volume as several pictures had to be taken to estimate the volume adequately.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V10-V16 | 150.857 percent change | — |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V16 | 786.937 percent change | — |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V6 | -17.300 percent change | Standard Deviation 90.9283 |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V6-V10 | -38.033 percent change | Standard Deviation 82.8031 |
| Vilobelimab 800 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V4 | -19.733 percent change | Standard Deviation 53.4282 |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V6-V10 | -100.000 percent change | — |
| Vilobelimab 1600 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V4 | 74.918 percent change | — |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V10-V16 | 4.167 percent change | Standard Deviation 177.7658 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V4 | -36.328 percent change | Standard Deviation 32.3445 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V6 | -58.959 percent change | Standard Deviation 46.7969 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V1-V16 | -92.639 percent change | Standard Deviation 15.658 |
| Vilobelimab 2400 mg Q2W | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | V6-V10 | -82.525 percent change | Standard Deviation 30.268 |
Secondary
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)
Population: Safety Set~Only patients with an available wound area measurement at both relevant visits (V1 and V16) are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilobelimab 800 mg Q2W | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | 15.14 mm²/day | — |
| Vilobelimab 1600 mg Q2W | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | -12.04 mm²/day | Standard Deviation 9.638 |
| Vilobelimab 2400 mg Q2W | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | -9.58 mm²/day | Standard Deviation 10.751 |
Secondary
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
Population: Safety Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vilobelimab 800 mg Q2W | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | NA days |
| Vilobelimab 1600 mg Q2W | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | NA days |
| Vilobelimab 2400 mg Q2W | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | 126 days |