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Monoclonal Antibodies
Vilobelimab for Pyoderma Gangrenosum
Phase 3
Recruiting
Research Sponsored by InflaRx GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older at the time of signing the informed consent
Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria: area of ≥ 5 cm2 at screening and baseline, circulated by intact skin, and evaluable by at least 2-dimensional measurement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 10 through study completion
Awards & highlights
Study Summary
This trial will test a new drug to see if it can treat ulcerative pyoderma gangrenosum, while monitoring safety and effectiveness.
Who is the study for?
Adults diagnosed with ulcerative pyoderma gangrenosum (PG) can join this trial. They must have a PG symptom score of 10 or more and at least one qualifying PG ulcer larger than 5 cm2. People are excluded if they've had certain treatments for PG, infections needing systemic treatment, vaccinations within two weeks before the trial starts, or previous exposure to vilobelimab.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a drug called vilobelimab against a placebo in treating ulcerative pyoderma gangrenosum. Participants will be randomly assigned to receive either vilobelimab or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects for vilobelimab aren't listed here, common side effects may include reactions at the injection site, increased risk of infection due to immune system suppression, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a skin ulcer larger than 5 cm2 that can be measured in two ways.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 10 through study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 10 through study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Efficacy of treatment with vilobelimab compared to placebo
Pain reduction
Side effects data
From 2022 Phase 2 trial • 19 Patients • NCT0397164317%
Wound infection
17%
Rash
17%
Blood creatinine increased
17%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vilobelimab 1600 mg Q2W
Vilobelimab 800 mg Q2W
Vilobelimab 2400 mg Q2W
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: vilobelimabExperimental Treatment1 Intervention
Patients will be treated with vilobelimab IV, Q2W for 26 weeks
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive placebo IV in the same schedule as patients in Arm 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vilobelimab
2019
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
InflaRx GmbHLead Sponsor
10 Previous Clinical Trials
970 Total Patients Enrolled
1 Trials studying Pyoderma Gangrenosum
19 Patients Enrolled for Pyoderma Gangrenosum
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any systemic treatment for PG in the last 4 weeks.I am 18 years old or older.I haven't taken antibiotics or anti-infectives for an infection in the last 2 weeks.I have been taking more than 10 mg/day of prednisone or its equivalent for the past 4 weeks.I have not received any vaccines in the 2 weeks before starting treatment.My ulcer is larger than 80 cm2.I have a target ulcer in my transplanted skin.I haven't started any new immune therapy for PG in the last 4 weeks, except for stable treatments for another condition.The doctor has confirmed that you have ulcerative pyoderma gangrenosum and your PARACELSUS score is 10 points or more. If your score is less than 10, the doctor needs to explain why they still think you have ulcerative pyoderma gangrenosum.I have a skin ulcer larger than 5 cm2 that can be measured in two ways.I have previously been treated with vilobelimab.I have not had surgery or negative pressure therapy on my ulcer in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: vilobelimab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to join this investigation?
"Clinicaltrials.gov indicates that this clinical trial is actively recruiting participants, posted on August 15th 2023 and last edited on the 18th of the same month."
Answered by AI
How many participants are currently within the scope of this research endeavor?
"Affirmative. The information on clinicaltrials.gov confirms that this medical trial, which was initially registered on August 15th 2023, is actively seeking participants. Approximately 90 individuals need to be enrolled from a single research centre."
Answered by AI
Has vilobelimab been granted federal authorization for clinical use?
"The safety of vilobelimab was judged to be a 3 on our team's scale, as multiple rounds of clinical data affirms its efficacy and offers reassurance regarding the drug's security."
Answered by AI
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