Adaptive phase III trial to investigate the efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum

Brief description of study

This study aims to find out if a new investigational drug, vilobelimab (also called IFX-1) is safe and effective in treating subjects 18 and older diagnosed Ulcerative Pyoderma Gangrenosum. Procedures include blood and urine tests, a physical examination, vital signs, body weight and height, an electrocardiogram (ECG), and full assessment of pyoderma ulcers.

Detailed description of study

Dr. Micheletti is conducting a clinical trial at the University of Pennsylvania in the Department of Dermatology to access the efficacy and safety of vilobelimab in patients who have Pyoderma Gangrenosum.. The study will measure if the study drug closes the ulcers of your skin. It will also measure if the study drug improves the severity of your disease (according to the study doctor and according to you) and if it improves your pain and your quality of life. This is a blinded, randomized study, meaning there is a 50% chance that you will receive vilobelimab and a 50% chance that you will receive placebo. Whether you receive active study drug or placebo is chosen at random. You will be compensated $ 50.00 for each completed study visit up to 18 visits totaling $900.00. Compensation will be provided by the Greenphire ClinCard.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research
Age: - 99 Years
Gender: All

Inclusion criteria

18 years or older at the time of signing the informed consent.

Exclusion criteria

Patient has a known history of tuberculosis, human immunodeficiency virus (HIV) infection or a known history of or a suspected current hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Patients with known congestive heart failure (New York Heart Association criteria Class III or IV)
Patients with known progressed liver disease (Child-Pugh class B or C).

Updated on 09 Mar 2024. Study ID: 854406

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