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Monoclonal Antibodies

vilobelimab 2400 mg Q2W for Pyoderma Gangrenosum

Phase 2
Waitlist Available
Research Sponsored by InflaRx GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start until v16 (day 189)
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Pyoderma Gangrenosum

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start until v16 (day 189)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start until v16 (day 189) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs)
Secondary study objectives
Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16
Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16
Number of Patients With 100% Decrease in Area of Target Ulcer at V16
+8 more

Side effects data

From 2022 Phase 2 trial • 19 Patients • NCT03971643
33%
Wound infection pseudomonas
33%
Wound infection
33%
Dermatitis contact
33%
Traumatic haematoma
17%
Endocarditis
17%
Cellulitis
17%
Intervertebral discitis
17%
Sepsis
17%
Pneumonia
17%
Impetigo
17%
Nasopharyngitis
17%
Actinic keratosis
17%
Urticaria
17%
Head injury
17%
Haemoglobin decreased
17%
Gingivitis
17%
Dermatitis
17%
Lichen planus
17%
Seborrhoeic dermatitis
17%
Urinary tract infection
17%
Skin laceration
17%
Glossitis
17%
Peptic ulcer
17%
Blood creatinine increased
17%
Superficial vein thrombosis
17%
Hypothyroidism
17%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vilobelimab 800 mg Q2W
Vilobelimab 1600 mg Q2W
Vilobelimab 2400 mg Q2W

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: vilobelimab 800 mg Q2WExperimental Treatment1 Intervention
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.
Group II: vilobelimab 2400 mg Q2WExperimental Treatment1 Intervention
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.
Group III: vilobelimab 1600 mg Q2WExperimental Treatment1 Intervention
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.
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
11 Previous Clinical Trials
1,071 Total Patients Enrolled
1 Trials studying Pyoderma Gangrenosum
90 Patients Enrolled for Pyoderma Gangrenosum
Innovaderm Research Inc.OTHER
48 Previous Clinical Trials
3,201 Total Patients Enrolled
Prof. Niels C. Riedemann, M.D., Ph.D.Study DirectorInflaRx GmbH
~3 spots leftby Oct 2025
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