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Vilobelimab

Clinical trials are investigating Vilobelimab in people with ulcerative pyoderma gangrenosum, a painful skin condition that can cause deep ulcers. These studies look at whether Vilobelimab is safe and effective, especially compared with placebo, and measure how well ulcers heal.

Table of contents

Trial overview

The source data includes one clinical trial of Vilobelimab in people with ulcerative pyoderma gangrenosum, a rare skin disease that can cause deep and painful ulcers.[1] The study was designed to test whether Vilobelimab could improve healing compared with placebo.[1]

Study design and phase

This was a Phase 3 trial, which is a late-stage study used to check how well a treatment works and how safe it is in a larger group of patients.[1] It was also randomized, double-blind, placebo-controlled, multicenter, and adaptive.[1]

Randomized means patients were placed into groups by chance.[1] Double-blind means neither the patients nor the study team knew who got Vilobelimab or placebo during the trial.[1] Placebo-controlled means the study compared Vilobelimab with an inactive treatment, so the results could be judged more fairly.[1]

Who participated

The trial enrolled 149 patients with ulcerative pyoderma gangrenosum.[1] The source data does not list more detailed entry rules, such as age limits or other health requirements.[1]

What was measured

The main endpoint, or main result the study wanted to measure, was the proportion of patients achieving complete closure of the target ulcer by the end of treatment.[1] Complete closure meant the ulcer was fully covered by new skin or scar tissue, with no drainage and no need for dressings, and this had to be confirmed at two study visits 2 weeks apart.[1]

This outcome focuses on real healing of the wound, not just smaller size or less pain.[1]

Trial interventions and comparison

The study compared Vilobelimab given by intravenous use with placebo given by intravenous use.[1] The trial record also lists several corticosteroid medicines, such as prednisolone, prednisone, dexamethasone, hydrocortisone, methylprednisolone, betamethasone, triamcinolone, cortisone acetate, and fludrocortisone, as part of the intervention record.[1]

In simple terms, the study was set up to see whether adding Vilobelimab led to better ulcer healing than the comparison treatment.[1]

What the study tracked over time

The trial measured healing up to and including the end of treatment visit.[1] The healing check had to be repeated at two visits 2 weeks apart to confirm that the ulcer was truly closed and not just temporarily improved.[1]

The study status is listed as Completed, which means the planned trial activities were finished.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05964413 Phase 3 Ulcerative pyoderma gangrenosum Completed 149

FAQ

  • What is being studied in Vilobelimab clinical trials? The trial is studying whether Vilobelimab helps people with ulcerative pyoderma gangrenosum heal their target ulcer better than placebo. The main focus is complete closure of the ulcer.
  • Who can take part in these trials? The trial is for patients with ulcerative pyoderma gangrenosum. Specific entry rules are not listed in the source data, so participation depends on the study's full screening criteria.
  • What phase is the Vilobelimab trial? The study is a Phase 3 trial. Phase 3 studies usually compare a treatment with a control, such as placebo, in a larger group of patients.
  • What outcome is measured in the trial? The main outcome is complete closure of the target ulcer by the end of treatment. This means the wound is fully covered by new skin or a scar and does not need drainage or dressings.
  • Is the Vilobelimab study still recruiting patients? No. The trial listed in the source data is completed. That means the planned study visits and data collection are finished.

Ongoing Clinical Trials on Vilobelimab

  • Study on Vilobelimab and Drug Combination for Treating Ulcerative Pyoderma Gangrenosum in Adults

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +2

Glossary

  • Ulcerative pyoderma gangrenosum: A rare skin disease that causes painful, deep ulcers. It can be hard to heal and may need long-term treatment.
  • Placebo: An inactive treatment that looks like the real study drug. It is used to compare results fairly.
  • Phase 3: A late-stage clinical trial that tests whether a treatment works well and is safe in a larger group of patients.
  • Randomized: Patients are assigned to treatment groups by chance. This helps make the comparison fair.
  • Double-blind: Neither the patients nor the study team know who gets the study drug or placebo during the trial. This helps reduce bias.
  • Multicenter: The trial is carried out at more than one hospital or clinic.
  • Adaptive trial: A study design that can allow planned changes as the trial goes on, based on the data collected.
  • Target ulcer: The main ulcer chosen for study measurements in a patient.
  • Complete re-epithelization: The wound is fully covered by a new skin layer. This is a sign that the ulcer has healed.
  • End of treatment (EOT): The last visit or time point when the study treatment period is finished.
  • Investigator: The study doctor or research team member who evaluates the patient and records trial results.

References