Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
vilobelimab · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| vilobelimab | DRUG | IV infusions of vilobelimab diluted in sodium chloride. |
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...
Vilobelimab is an investigational small molecule being studied for the treatment of Pyoderma Gangrenosum, a rare inflammatory skin condition. It is developed by InflaRx N.V. and is currently in Phase 2 clinical development. The drug has received Orphan Drug and Fast Track designations from the FDA.
Vilobelimab targets the complement system, specifically the complement component C5a. By inhibiting C5a, the drug aims to reduce the inflammatory response that contributes to the tissue damage seen in Pyoderma Gangrenosum. This mechanism is being evaluated in clinical trials for its potential to treat this condition.
Vilobelimab is developed by InflaRx N.V., a biopharmaceutical company traded under the ticker symbol IFRX. The company is conducting clinical research on this drug for Pyoderma Gangrenosum, with a completed Phase 2 trial involving 19 patients.
Vilobelimab is in Phase 2 clinical development for Pyoderma Gangrenosum. It is not yet approved by the FDA and remains investigational. The drug has received Orphan Drug and Fast Track designations, which are intended to expedite its development and review process.
Vilobelimab has one completed clinical trial, identified as NCT03971643, titled 'Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum'. This Phase 2 study enrolled 19 participants and was conducted in the United States, Canada, and Poland. The trial was controlled but not randomized or double-blinded.
Yes, vilobelimab is also known as IFX-1. The clinical trial NCT03971643 refers to the drug as IFX-1 in its title. This alternative name is used in research contexts, and both names refer to the same investigational drug developed by InflaRx N.V.