Phase 2
N=19
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
Pyoderma Gangrenosum
Bottom Line
View on ClinicalTrials.gov: NCT03971643 ↗Enrolled (actual)
19
Serious AEs
21.1%
Results posted
Sep 2023
Primary outcome: Primary: Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) — 6; 4; 5; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vilobelimab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- InflaRx GmbH
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) |
6; 4; 5; 0; 2; 2 | — |
| SECONDARY Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) |
2; 0; 0; 1; 1; 3 | — |
| SECONDARY Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] |
NA; NA; 126 | — |
| SECONDARY Percentage Change in Wound Healing (Wound Area) by Photographic Assessment |
-13.612; 16.099; -12.620; -4.130; -8.413; -34.153 | — |
| SECONDARY Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment |
-19.733; 74.918; -36.328; -17.300; -58.959; 786.937 | — |
| SECONDARY Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 |
15.14; -12.04; -9.58 | — |
| SECONDARY Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 |
0; 1; 6 | — |
| SECONDARY Number of Patients With 100% Decrease in Area of Target Ulcer at V16 |
0; 1; 2 | — |
| SECONDARY Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 |
-41.6; 10.6; -41.4; -43.3; 1.7; -45.0 | — |
| SECONDARY Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 |
-29.9; -3.8; -33.1; -31.4; -33.2; -24.7 | — |
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.
Eligibility Criteria
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 bowel disease or inflammatory arthritis
- History of papule, pustule or vesicle that rapidly ulcerated
Clinical examination (or photographic evidence) of
- Peripheral erythema, undermining border, and tenderness at site of ulceration
- Multiple ulcerations (at least 1 occurring on the lower leg)
- Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers
Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening
Exclusion Criteria
- Pyoderma gangrenosum target ulcer for more than 3 years before screening
- Surgical wound debridement within the previous 2 weeks before screening
- Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
- Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
Data sourced from ClinicalTrials.gov (NCT03971643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.